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Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
概要
愛知工場のGMP上位文書がGMP要求事項及びBMS品質要求事項に準拠し、機能することを保証する責任を持つ。
- 愛知工場GMP上位文書の各担当部門での運用状況を査察/点検し、愛知工場GMP上位文書がGMPの要求事項を満たし機能していることを保証する。
- 愛知工場の文書管理及び教育管理のSubject Matter Expert (SME)として、BMS Globalとのコミュニケーションを持ち、システムを適切に維持する。
役割と責任範囲
- 会社及び部門全体の方針を理解し、品質方針・品質目標・品質計画を策定する。
- 品質方針・品質目標・品質計画をもとに品質マネジメントシステムの各プロセスを維持・管理する。
- 各プロセスの責任者と効果的なコミュニケ―ションを取り、各プロセス責任者を指揮し、品質方針・品質目標・品質計画を実行する。
以下のプロセスを通じ愛知工場サイトの法規制遵守を保証する。
- 文書管理及び教育訓練に関して、愛知工場の責任者／システム管理者としてシステム運用の規制要求への準拠を保証する。また、システムの運用管理状況を計測するMetricsを設定して管理を行う。
- 文書管理及び教育訓練に関して、海外チームと連携を行い、適切な維持管理を行う。
- 愛知工場の文書全体を適切に管理するためのシステムを構築する。
- 教育訓練プログラムの運用及び維持管理を適切に行い、従業員がGMPの作業を行う適正な能力を有することを保証する。
- 愛知工場のBMS品質要求事項（QUALITY MANAGEMENT SYSTEM FRAMEWORK）のSite Coordinatorとして、サイトコンプライアンス評価の管理を行い、システム毎のSMEと連携し、愛知工場GMP上位文書が最新のBMS品質要求事項に適合していることを保証する。
- 製品品質の照査（Annual Product Quality Review, APQR）のSite Coordinatorとして、規制当局及びBMS要求事項との準拠を保証する。また、関連部署と連携してAPQR作成をコーディネートするとともに、スケジュール管理を行う。
- 製品標準書のSMEとして、規制当局及びBMS要求事項との準拠を保証する。また、製品標準書の作成及び改訂等の総合的な維持管理を行う。
- 品質試験に関する文書レビューを行い、承認書との適合性を保証する。
その他付随業務（課共通）
- 海外サイトとのグローバルプロジェクトに参画する。
- 作業が効率的か常に考え、改善活動を実践する。
- 法規制および BMS の基準等を遵守するように部署の EHS・安全衛生に責任を持つ。
必要な知識/スキル
- 国内外のGMP要求事項及び日本の薬事対応の専門知識
- 医薬品の品質システム業務を遂行する上での標準的な知識/スキル
- チームメンバーに対し、スキルアップを意識した教育・指導能力
- 品質システムの課題を見出し、実行可能な改善計画を提案できる経験能力
- 他部門を巻き込んだプロジェクトに参加して成果を得ることができる
- 客観的事実と外部情報、適切なリスク評価に基づき、問題を分析し、解決することが出来る。
- 品質システムなどの課題に対し課題解決のための提案や交渉が出来る。
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Position Summary
- Provide appropriate CMC regulatory strategy in each stage of development, approval review (JNDA/sJNDA), and life cycle management in order to achieve BMSKK business goal, and execute tasks according to this strategy. For that objective, obtain information from the inside/outside of BMSKK and understand the latest regulatory requirements. In addition, communicate appropriately with regulatory authorities (Pharmaceuticals and Medical Devices Agency (PMDA) / Ministry of Health, Labour and Welfare).
- Take part in the development team and JNDA/sJNDA team. Propose CMC regulatory strategy by himself or herself, and execute tasks. Align with colleagues for not only task execution but also knowledge/skill acquisition.
Roles& Responsibilities
Fulfill his/her responsibilities in the stage of development, approval review (JNDA/sJNDA) and life cycle management while considering the instruction/guidance from supervisors/superiors based on his/her own judgement.
- Carry out risk assessment in each stage. As necessary, propose and implement risk management plan.
- Contribute to cross-functional team through having regulatory discussion from CMC regulatory aspects and providing appropriate information regarding the development strategy.
- Provide regulatory and technical advice to related parties including Global teams.
- Align with colleagues for not only task execution but also knowledge/skill acquisition.
- Support junior colleagues’ responsibilities.
Development:
- Provide information needed for Clinical Trial Notification (CTN). If necessary, cooperate with global team and prepare CMC-related attached documents for CTN in consideration of submission timing.
- Provide information to Global team in order to develop pharmaceutical products that are acceptable in Japan.
- Evaluate the necessity of PMDA consultation for biologics based on outcomes of other countries in collaboration with Global team, if critical manufacturing process change is needed and/or development plan, which will impact products quality, is developed.
- Evaluate excipients from viewpoints of new excipients (precedence of excipients) and biological ingredients standard and share the information to relevant department if necessary.
Approval review (JNDA/sJNDA):
- PMDA Consultation: Plan strategies and gain agreement through discussion with Global team in order to receive expected response. Prepare documents according to the strategies.
- CTD Preparation: Prepare CTD through discussion with Global team that the contents of CTD meet the regulatory requirements and are aligned with agreement with Global team.
- GMP/GCTP inspection: Provide the information on the manufacturing sites, etc. listed in the application form for marketing approval to the lead department, and provide support. In the on-site inspection, accompany as a member of the marketing authorization holder and support the inspection mainly from the viewpoint of the content of the application form for marketing approval.
- Communication with the authorities: Regarding the PMDA consultations and approval review etc., submit responses prepared as outlined in the agreement of Global team through explanation on meaning of queries, discussion and negotiation for generation of the best responses. Plan to hold a F2F meeting with the authorities, if necessary.
Life cycle management:
- Based on the information of change control initiated by manufacturing department, propose appropriate regulatory strategy and execute regulatory tasks in the point of view of product supply and the situation of Product Assurance and Marketing.
- Control approval timing of the partial change application based on the information of manufacturing department.
- If inquiries on commercial products arises from outside of BMS, take appropriate actions in cooperation with related parties (Medical information, etc.).
- Facilitate inquiries/support from the parties related the product quality (manufacturing department, GQP, etc.).
- Inform supervisor when negotiation with other parties is necessary in order to facilitate task related to the life cycle management.
Qualifications
Experience and knowledge in many of the following application items (JNDA/sJNDA and Partial Change Application)
- Preparation of application documents (Application form and CTD)
- Preparation of submission documents for Minor Change Notification
- JAN application
- GMP/GCTP inspection (domestic and overseas)
- Foreign Manufacturer Accreditation
- Master File (coordination with In-Country Caretaker)
Experience or knowledge in many of the following items;
- Japanese Pharmacopoeia
- Organic synthesis, chemical analysis, protein chemistry, biochemistry, and microbiology
- Pharmaceutical development
- Manufacturing control and quality control (GMP, GCTP, GQP)
English Communication skill
- Can attend meetings (including audio conference) with global teams and carry out tasks by him/herself.
Negotiation skills
Leadership skills
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Senior Manager, Quality Control (QC) – Aichi, Japan
Position Summary: Bristol Myers Squibb is seeking a highly skilled and experienced Senior Manager to lead our Quality Control (QC) team in Aichi, Japan. As the Head of QC at our Aichi laboratory, you will play a critical role in ensuring the quality and safety of our pharmaceutical products through rigorous testing of small molecule and biological medicines. This position oversees a broad scope of activities, including release and stability testing of locally manufactured products, import testing, raw material inspection, environmental monitoring, and microbiology. The role is essential in maintaining compliance with Japan's cGMP standards, Bristol Myers Squibb's internal quality standards, and supply chain demands.
Key Responsibilities:
- Lead and manage the QC organization at the Aichi laboratory, overseeing the testing and inspection of raw materials, bulk and final drug products, environmental monitoring, microbiology, and stability.
- Ensure all analyses meet current Japanese Good Manufacturing Practice (cGMP) standards and BMS quality standards, supporting timely product release and ensuring supply chain efficiency.
- Support Quality Operations and In-Market Quality teams by providing accurate and timely test results for product release decisions.
- Maintain strong connections within the global QC network to align the Aichi laboratory as a key part of BMS’s overall analytical testing strategy.
- Contribute to the development and execution of the network's analytical strategy, ensuring its successful deployment at the Aichi site.
- Lead a talented and growing QC team, fostering a culture of safety, continuous improvement and high performance.
- Collaborate with Japan stakeholders, including GQP, CMC, and regulatory bodies (e.g., PMDA), to provide analytical support and address regulatory inquiries.
- Proactively manage analytical issues.
Qualifications
- Bachelor’s or master’s degree (MSc) in analytical chemistry, biochemistry, pharmacy, or related fields, a PhD in the same disciplines is plus.
- 7-10 years of experience in pharmaceutical manufacturing, quality control, or quality assurance, along with sufficient knowledge to assume the role.
- Knowledge and thorough understanding of ICH, PICS, Japanese and international cGMP.
- Advanced leadership and people management skills.
- Change Agent.
- Problem solving mindset and sense of urgency.
- Requires strategic thinking and ability to work in a matrix environment.
- Ability to interpret/write general, technical, and complex business documents.
- Advanced presentation skills.
- Able to write, read, and speak English fluently
Why Join Us? At Bristol Myers Squibb, you will be a part of a diverse and global QC organization that is dedicated to delivering innovative medicines that help patients prevail over serious diseases. As a leader in the QC team, you will play a pivotal role in ensuring the safety and quality of life-saving therapies distributed across Japan, while having the opportunity to develop and grow alongside a world-class team.
Apply Today! Join us in making a difference in the lives of patients. Apply now to become a part of our dynamic team at Bristol Myers Squibb.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Position Summary
- Supporting the production of personalized cell therapy products for both clinical trials and commercial supply in region
- Providing day-to-day manufacturing support
- Leading manufacturing investigations pertaining to the process control strategy and associated elements
- Managing CPV and process monitoring program
- Support development and lifecycle management of MBR, SOP, and/or eBR
- Managing multidisciplinary projects aimed at improving the process and/or drug product life cycle sustainability
- Support creation/revision of documentation (i.e. SOP, change control, validation documentation, technical reports, etc.) required to support the production of personalized cell therapy products
- Cross-functional collaboration with SMEs from the Development Group, Manufacturing Group, Supply Chain Group, and Quality Group is essential to ensuring technical support is delivered to a rapidly growing CAR-T manufacturing organization
Key Responsibilities
- Provide on the floor or remote process support for ongoing manufacturing activities when needed.
- Review and approve manufacturing batch records, change controls, and deviations authored by the CMO.
- Lead deviation investigations utilizing root cause analysis tools.
- Lead product impact assessments to support investigations.
- Assist with revisions of the content of technical documentation (e.g. investigations, changes, SOPs and batch records).
- Interact with other teams including Technical Product Team, Validation, Development, Operations, QA and Regulatory.
- Participate in routine plant operating meetings.
- Proven ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements accurately and completely.
- Support health authority and/or internal inspections.
- Write & review guideline procedures, protocols, and reports in Japanese and English.
- Work as a process SME to support clinical and commercial manufacturing, troubleshooting, deviation investigations and identify appropriate CAPAs.
- Oversee and perform manufacturing data trending to contribute to the lifecycle management of a process.
- Support process changes during the lifecycle.
- Train end-users and entry-level personnel on the manufacturing process.
- Interact with other CMC teams, Quality Operation, Clinical Operation, Regulatory, Facility and other personnel as dictated by project needs.
- Support tech transfer SME and help drive best practices and technical advancements.
- Flexibility to work multiple time zones as needed.
Qualifications & Experience
Specific Knowledge, Skills, Abilities:
- Knowledge of cGMPs and multi-national biopharmaceutical regulations. Cell therapy and/or Aseptic processing experience is a major plus.
- Must have excellent organization skills and ability to handle multiple tasks.
- Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.
- Possess strong verbal/written communication skills both in Japanese and English.
- Ability to think strategically and to translate strategy into actions.
Education/Experience/ Licenses/Certifications:
- Master’s or Bachelor’s Degree in in cell biology, biotechnology, biochemistry, Engineering, Life Science or equivalent with minimum of 5 years relevant experience in biologic process/analytical development or commercial biologic manufacturing process support.
- Experience with cell culture or aseptic techniques is preferred.
- Experience in a regulated, GMP manufacturing environment is required.
- Experience with cGMP, ICH guidelines, PPQ (process validation), and working within a Quality organization.
- Previous experience with CMOs is preferred.
- Experience with regulatory agency inspections and regulatory responses is a plus.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Drug Discovery Research
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
When you join BMS, you are joining a diverse, high-achieving team united by a common mission.
Bristol Myers Squibb encompasses a broad range of disciplines to enable a robust pipeline of drug candidates aimed at serious diseases. Chemistry is a core capability in Small Molecule & Drug Discovery with innovative scientists working in medicinal chemistry, radiochemistry, analytical chemistry, and large-scale synthesis. Within SMDD our Lead Discovery and Optimization (LDO) team is responsible for high throughput screening, compound storage and distribution, primary assays to support discovery programs, and compound profiling to explore drug liabilities in vitro. LDO scientists discover and adopt cutting edge assay technologies that utilize state-of-the-art automation to drive speed and efficiency. Our Molecular Structure and Design team embraces novel approaches to computer-aided drug design, machine learning, and structural biology. The integration of these disciplines provides a seamless and highly interactive environment for discovery scientists to learn, develop, and innovate. Working in partnership with our disease area experts in the Thematic Research Centers provides an exciting pathway to discover and deliver medicines to patients in need.
The Cheminformatics team within Bristol Myers Squibb is seeking an exceptional scientist with an interest in the use of artificial intelligence and machine learning for molecular design. In this role, the selected candidate will use cutting edge techniques to accelerate the drug discovery process from hit identification through candidate nomination and will actively participate directly on therapeutic projects.
The scientist must have a broad knowledge of modern data science methods with an emphasis on machine learning to advance multi-objective molecular design efforts. We are looking for expertise in generative molecular design with applications to therapeutic projects. The successful candidate must have a sufficient understanding of chemistry and the ability to communicate with collaborative scientists from a broad array of backgrounds. Key objectives for this position will be to identify and use machine learning methods to drive chemical structure optimization within the context of therapeutic projects, and to enable other scientists within the team to benefit from those tools and methods in their projects.
The selected candidate will join a research team with a track record of pipeline impact across modalities and across therapeutic areas. This is an exciting opportunity as we combine the best of physics-based modeling with data analytics and machine learning to accelerate drug discovery and bring benefit to patients.
Basic Qualifications:
Bachelor’s Degree with 5+ years of academic / industry experience
Or
Master’s Degree with 3+ years of academic / industry experience
Or
Ph.D. and no experience required
Preferred Qualifications:
Ph.D. with 0- 2+ years of relevant fields with a focus in Artificial Intelligence or Machine Learning development and applications to molecular design. Postdoctoral or industry experience a plus.
Experience in machine learning or artificial intelligence work is critical, with cheminformatics, computational chemistry, and/or molecular modeling experience a plus.
Proficiency in programming and scripting languages such as Python, C/C++, and/or R etc.
Expertise in a subset of machine learning and cheminformatics libraries, such as TensorFlow, Kera’s, PyTorch, Pandas, Scikit-Learn, DeepChem, RDKit or OEchem is essential.
Sensitive to data. Critical assessment of experimental data and combinations of different data sets. Incorporate data knowledge into development and application of suitable machine learning algorithms to produce meaningful predictive models.
This position will be operating in a multidisciplinary environment and a willingness to collaborate across functional teams is essential.
An aptitude and desire to learn and apply new techniques is expected as well as personal attributes of integrity, creativity, problem solving, and a strong work ethic.
Excellent communication skills are a must.
Track record of publications on peer-reviewed scientific journals.
The starting compensation for this job is a range from $97,000 - $135,300 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
The Senior Director – Clinical Pharmacology will be a key member of the development team, developing clinical pharmacology strategy, leading the design, execution, interpretation and reporting of clinical pharmacology data, and serve as clinical pharmacology lead on studies and project teams. The role will support projects at various stages of development, playing an active role in our drug discovery and development efforts to advance RayzeBio’s radiopharmaceutical pipeline.
Job Responsibilities:
Essential duties and responsibilities include the following. Other duties may be assigned.
Develop clinical pharmacology strategy and related clinical development plan consistent with the development strategy, program goals, and the US/international regulatory guidance for radiopharmaceuticals.
Collaborate with DMPK, clinical development, and CMC teams to define clinical pharmacology data needed to support NDA and drug label.
Determine scope, design, plan, analyze and interpret pharmacokinetic and pharmacodynamics (PK/PD) in company-sponsored studies, including development of appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from concept stage to commercialization.
Provide clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Development, Biometrics, and Regulatory Affairs.
Contribute to the design and execution of Phase 1 clinical pharmacology (eg, drug-drug interactions, relative bioavailability/bioequivalence, special populations, and thorough QT, etc.) and dosimetry studies.
Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial documents.
Plan, prepare, and review clinical pharmacology section of the regulatory documents (IND, IMPD, IB, NDA CTD, etc.), participate in drafting publications and making scientific presentations consistent with development strategies.
Serve as the primary Clinical Pharmacology Lead and effectively participate in cross functional teams to ensure integration of clinical pharmacology principles into project plans and study design.
Represent clinical pharmacology at regulatory meetings and advisory hearings with global health authorities.
Other duties as assigned.
Willing to travel up to approximately 10% of the time (if not based in San Diego area).
Education and Experience:
PhD, MD or PharmD with at least 8-10 years of pharmaceutical or biotech experience in clinical pharmacology and oncology drug development.
Experience with early and late-stage clinical development, IND and filing dossier
Radiopharmaceutical experience is preferred but not required.
Skills and Qualifications:
Patient-focused, with deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeutics
Motivated to work in a fast-paced, high accountability, small company environment. A "can do" and collegial professional who leads through influence and interpersonal skills.
Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to detail.
Demonstrated ability to collaborate successfully with multiple functions in a team environment.
Intellectually curious with courage to challenge and seek new ways to improve work.
Strong written and oral communication skills, including presentation skills.
Ability to analyze and interpret data and develop written reports and presentations of those data.
Strong critical, strategic, and analytical thinking skills.
Strong background and expertise in Clinical Pharmacology, PK and PK/PD demonstrated by major Regulatory submission experience and/or scientific publications.
Proven ability to manage strategic, scientific and operational aspects of development projects from a Clinical Pharmacology perspective.
Skilled in clinical research and understand the process of pharmaceutical product development and approval.
Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP’s).
Solid understanding of GCP and ICH guidelines.
Physical demands:
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.
Work Environment:
The noise level in the work environment is usually moderate.
The starting compensation for this job is a range from $234,726-$317,571 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
#RayzeBio
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC) and breast cancer. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
The Vice President, Head of Pharmacovigilance - Safety Science, is responsible for overseeing all aspects of product safety across clinical development and post-marketing surveillance. This key leadership role ensures that pharmacovigilance (PV) activities align with regulatory requirements and company standards, and drives the strategy and execution of safety science to protect patient health and optimize product benefit-risk profiles. The VP works cross-functionally with clinical, regulatory, medical affairs, quality, and commercial teams to support the safe use of products globally.
Responsibilities
Pharmacovigilance Strategy and Oversight
·Develop and lead the global pharmacovigilance strategy to ensure proactive risk management and compliance with local and international PV regulations (e.g., FDA, EMA, ICH).
·Oversee end-to-end PV activities, including case processing, safety surveillance, risk management, and signal detection and assessment.
·Establish and maintain robust safety governance structures, ensuring alignment with company objectives and industry best practices.
Safety Science and Risk Management
·Direct safety evaluation and risk management for clinical and post-marketing products, including benefit-risk assessments, aggregate reporting, and product safety strategy.
·Lead the detection, evaluation, and management of safety signals, collaborating with cross-functional teams to implement risk minimization strategies and communicate potential safety concerns.
·Oversee safety aspects of regulatory submissions, periodic safety reports (e.g., DSURs, PSURs, RMPs), and responses to regulatory inquiries.
Cross-Functional Leadership and Stakeholder Engagement
·Partner with clinical, regulatory, and medical affairs teams to integrate safety insights into product development, clinical trial design, and labeling strategies.
·Act as the key PV representative for interactions with global regulatory authorities and stakeholders, advocating for patient safety.
·Engage with external experts, scientific bodies, and industry groups to stay updated on evolving PV practices and enhance the organization’s safety profile.
Team Leadership and Development
·Lead and mentor a high-performing pharmacovigilance and safety science team, fostering a culture of collaboration, accountability, and scientific excellence.
·Define and implement processes for continuous improvement within PV operations, safety science, and risk management.
·Manage the PV budget, ensuring alignment with organizational priorities and effective use of resources.
·Up to 25% travel if not located in San Diego.
Education and Experience
·MD, PharmD, PhD, or other advanced degree in a relevant field.
·15+ years of experience in pharmacovigilance, safety science, or related area within the pharmaceutical/biotechnology industry, with a proven track record of leadership. Experience in Solid Tumors Oncology is required.
·In-depth knowledge of global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH.
·Strong understanding of clinical development, post-marketing safety, and regulatory submissions.
·Demonstrated expertise in signal detection, risk management, benefit-risk assessment, and aggregate safety reporting.
·Experience interacting with global regulatory authorities and scientific advisory bodies.
·Exceptional leadership, strategic thinking, and communication skills.
Skills and Qualifications
·Experience leading a large team within a global organization.
·Proven ability to work effectively in a matrixed, cross-functional environment.
·Demonstrated commitment to patient safety and ethics in medical practice.
The starting compensation for this job is a range from $312,000 - $390,000 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
#RayzeBio
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Drug Discovery Research
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Director Protein Production and Quality Attributes (San Diego, California or Cambridge, Massachusetts, USA)
When you join BMS, you are joining a diverse, high-achieving team united by a common mission.
The Discovery Biotherapeutics team at BMS seeks to understand the structure and function of complex molecules such as bispecific antibodies, antibody drug conjugates and endogenous proteins in order to optimize their utility as therapeutic agents. We collaborate with biology and translational scientists imbedded in the Thematic Research Centers in order to prosecute Targets and Biological pathways with disease modifying potential. By using a blend of internal and external technologies and capabilities, we work to discover and deliver first-in-class as well as best-in-class molecules that warrant clinical evaluation for patient benefit.
Here, you’ll get the chance to grow and thrive through opportunities that are uncommon in scale and scope. You’ll pursue innovative ideas while advancing professionally alongside some of the brightest minds in biopharma.
As part of the Discovery Biotherapeutics team at BMS, the Director of Protein Production and Quality Attributes will play a key role in supporting the delivery of a first-in-class and best-in-class biotherapeutics pipeline. The incumbent will be responsible for leading a team of about 25 scientists across two BMS sites located in San Diego (CA) and Cambridge (MA). The primary responsibilities include managing a cross-site and cross-functional team focused on the production and characterization of monoclonal antibodies, multi-specifics, antibody-drug conjugates (ADCs), and other protein therapeutics using state-of-the-art technology and an industry-competitive DNA-to-protein production process. The Director role will be crucial in innovating and advancing Discovery Biotherapeutics function capabilities, supporting drug development initiatives, and ensuring the success of BMS's research activities.
You will work in close collaboration with scientific leaders across the global Research organization and beyond (e.g., Biologics Drug Product/CMC teams) to deliver on our biologics pipeline. You must have a thorough understanding of biologics modalities production end-to-end (i.e., from cloning to purification and quality analyses) in high-throughput, mid, and large-scale settings, with documented experience of the requirements and processes needed to advance biologics programs (including novel formats) through discovery and into development. A proven track record of establishing and/or using cutting-edge protein cloning, production, and purification technologies to progress an innovative biologics pipeline is key.
Responsibilities:
- Manage, mentor, and develop a high-performing team (consisting of PhD and non-PhD scientists) dedicated to excellence in biologics cloning, production, purification with a focus on strategic goal setting and talent management.
- Apply deep scientific knowledge of protein production, concepts, and methodologies to deliver on biotherapeutics pipeline in alignment with Discovery Biotherapeutics, including being point person for interactions with CMC colleagues.
- Manage high-throughput, medium, and large-scale production of biologics end-to-end (i.e., from cloning to production, purification, and formulation).
- Advance cloning and purification platforms to produce and characterize monoclonal and bispecific antibodies, fusion proteins, and ADCs.
- Apply protein structural and biophysical principles to optimize the production and manufacturability of therapeutic candidates.
- Identify and implement new technologies, applications, and external collaborations to support research goals including participating in licensing and technology evaluation of platforms as relate to the job function.
- Interface with technology providers to keep on par with industry leading protein cloning, production, purification, and manufacturability.
- Foster a continuous improvement mentality to drive platform development in terms of speed, quality, and robustness, ensuring global biologics remain aligned with industrial standards.
- Integrate analytical characterization data to optimize biologics production.
- Ensure clear communication among team members and across teams to foster a culture of proactive collaboration and engagement.
Basic Qualifications:
Bachelor's Degree with 15+ years of academic / industry experience
or
Master's Degree with 12+ years of academic / industry experience
or
PhD with 8+ years of academic / industry experience with 6+ years leadership experience.
Preferred Qualifications:
- A Ph.D. in Biochemistry, Biotechnology, Molecular Biology, or a related field
- 10+ years of increasing responsibilities and experience in protein cloning, production, purification, and quality analyses, preferably in an industry setting.
- Demonstrated leadership and people management skills, with the ability to effectively lead and manage teams.
- Strong strategic vision and experience in developing and executing strategic plans that align with organizational goals.
- Excellent analytical and problem-solving skills, with the ability to identify challenges and propose innovative solutions.
- Exceptional communication and collaboration skills, with the ability to effectively interact with cross-functional teams and stakeholders at all levels.
- Hands-on experience with CHO and other mammalian cells for mAb or recombinant protein production is a must.
- Experience in tech transfer, including drafting reports, protocols, and knowledge for process transfer.
- Demonstrated ability to successfully and efficiently coordinate multiple work streams and projects simultaneous.
- Track record of scientific publications and presentations at meetings, or authorship of patents and regulatory documents.
The starting compensation for this job is a range from $194,000 - $268,400 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Scientist Bioanalytical
When you join BMS, you are joining a diverse, high-achieving team united by a common mission.
The Pharmaceutical Candidate Optimization organization at Bristol Myers Squibb is a dynamic, multi-disciplinary department that works to discover and optimize new drug candidates. We work across all therapeutic areas and all modalities (small molecules, biotherapeutics, gene and cell therapies and other novel modalities), and engage with all other R&D functions to advance new assets in the BMS portfolio. Our integrated, cross-functional teams apply deep expertise in drug metabolism, pharmacokinetics (DMPK), toxicology, pharmaceutics, and bioanalysis to identify and solve issues, discover high quality drug candidates, and enable their clinical development.
Here, you’ll get the chance to grow and thrive through opportunities that are uncommon in scale and scope. You’ll pursue innovative ideas while advancing professionally alongside some of the brightest minds in biopharma.
The successful applicant will be primarily responsible for the following:
- Enable and ensure overall high level instrument performance for bioanalysis performed on low-flow/high resolution mass spectrometers.
- Generate high quality analytical data in support of complex bioanalytical assays
- Developing or help develop new assays for the quantification of targeted endogenous proteins in biological samples (plasma, tissue homogenates, etc.) using LC-MS in close collaboration with group members
- Working in a team environment to optimize bioanalytical assays utilizing complex sample preparation techniques, including off-line peptide separation, immuno-precipitation, and SPE.
- Collaborating in a multidisciplinary research environment to address bioanalytical issues related to discovery programs and provide input into bioanalytical strategies.
- Representing the department on project teams and present data at internal department and / or other company meetings as well as external conferences.
- Maintaining good laboratory practices and documentation (ELN)
Basic Qualifications:
- Bachelor's Degree and 5+ years of academic or industry experience
- Or
- Master’s Degree and 3+ years of academic or industry experience
- Or
- PhD and no years of experience
Preferred Qualifications:
- PhD and 1 to 2 years of a post doc in analytical chemistry, biochemistry or related discipline with relevant experience and emphasis on proteomics/protein quantitation and quantitative mass spectrometry
- Hands-on experience with High-Resolution mass spectrometers (Thermo Tribrids, Exploris) and familiarity with software platforms (Protein Discoverer, Skyline, Spectronaut, etc.) is a must
- Hands-on experience with different sample preparation procedures such as protein precipitation, immune-precipitation, liquid-liquid extraction, solid-phase extraction, etc. is preferred
- Ability to independently diagnose and solve complex technical and scientific problems.
- Ability to troubleshoot and perform minor instrument repairs to maintain highest performance and minimize downtime, preference for technical abilities to maintain and troubleshoot low flow LC- high resolution MS systems.
- Self-motivated with excellent communication, organizational and interpersonal skills. Able to effectively manage and interface with others in a matrix team environment.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Position Summary: Manager Automation Engineer is responsible for the administration, maintenance, and improvement of the Building Automation software and Equipment Monitoring System at BMS Bothell.
Duties/Responsibilities:
- Author, review, approve, and execute qualification protocols for changes to the existing automation systems and the implementation of new systems
- Acting subject matter expert (SME) for the Building and Equipment Monitoring System
- Provide training, expertise, and guidance to fellow technicians and to other departments, as necessary to maintain business operations and drive continuous improvement
- Project subject matter expertise to influence the design process and integration of Building Automation and Equipment Monitoring systems using WebCTRL, or other automation platforms
- Work in partnership with vendors on investigations of proprietary automation software, hardware and systems
- Management of automation related engineering drawings to ensure drawings are accurate, up-to-date, and stored in accordance with industry guidance and applicable procedures
- Participate in on-call support for automation control troubleshooting and repair
- Provide and perform maintenance, installation, calibration or mechanical/electrical equipment while complying with current Good Manufacturing Practices
- All work to be completed to assure minimal impact to production, while complying with cGMPs at BMS Bothell
- Establish and adhere to all safety procedures and practices affecting building facilities and utilities
- Participates in establishing facility, utility, automation, and calibration practices, policies, and procedures, including operation and maintenance SOPs
- Support development of validation documentation for new equipment, systems, and control programs
- Execute validation protocols to support in the qualification on the Building Automation System
- Utilize the site's Building Automation/Maintenance System (BAS/BMS) to monitor and troubleshoot building utilities, process equipment, and leverage the BAS for system health indicators
- Provide training, expertise, and guidance to fellow technicians and to other departments, as necessary to maintain business operations and drive continuous improvement
- Provide oversight to and manage automation related projects to ensure minimal impact to production
- Development and implementation of new control programs for new and existing equipment to meet user requirements, meet the needs of the business, and maintain compliance with cGMPs and industry best practices
- Drive continuous improvement of existing automation systems, develop new capabilities, and manage and organize all changes within existing quality systems
- Develop, implement, and improve training of the BAS and automation systems
- Installation and activation of new monitoring points in the BAS/EMS
Qualifications:
Education:
- A bachelor’s degree in science or engineering discipline or a related field is preferred.
Experience:
- 5+ years related experience in building automation/maintenance specifically including HVAC/air handling systems, controlled processing equipment, heating/cooling systems, plumbing and piping systems, and power/lighting Advanced knowledge of Building Automation/Management Systems, such as WebCTRL's Automated Logic
- Knowledge of Blue Mountain BMRAM or other computerized maintenance management systems
- A minimum of 1 year working directly with instrumentation and/or asset management systems is preferred.
- Requires expanded conceptual and practical knowledge in the operation, administration, and management of a Building Automation System to support manufacturing operations
- Knowledgeable in installation and maintenance of electrical equipment. Working knowledge of Power Distribution Systems, UPS Systems, Variable Speed Drives, Emergency Generators, Motors, Breakers and Motor Control Centers. Typically, has received training in such specialized subjects as electrical theory, electrical controls, analog and digital electronics Direct experience installing, commissioning, administering, and maintaining automation systems and associated instrumentation
- Proven experience solving a variety of problems, analyzing possible solutions, and presenting solutions/implementing solutions as appropriate
- Ability to manage work independently while still maintaining a high level of collaboration to gain understanding and participate in established site processes
- Experience with WebCTRL Automated Logic
- Proven expertise in implementing, maintain, and improving automation systems in a GMP manufacturing facility
- Knowledge of Blue Mountain BMRAM or other CMMS
- Proven expertise in troubleshooting and repair of electro/mechanical systems
- Unwavering commitment to implement and follow safety protocols and work practices
- Ability to respond to off-hours emergencies, including nights, weekends, and holidays
- Customer service focused for cross-functional support
- Strong quality mindset to ensure that all work is conducted in accordance with applicable standards, guidelines, or procedures
- Strong attention to detail and follow-through
- Ability to multi-task in a fast-paced environment
- Self-motivated, pro-active, and able to work with minimal supervision
- Demonstrated success working in a high-performing, business results-driven environment
- Broad knowledge of operations of instruments including startup, normal operations, shutdown and non-typical operational modes
- Excellent written and verbal communication skills
The starting compensation for this job is a range from $92,000 to $121,000, plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
BMSCART
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.