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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. 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.
IO Account Executive 免疫肿瘤客户主任
主要职责 (岗位相关):
• 有深入的产品知识和疾病领域知识
• 达成/超越区域目标
• 执行市场经理阐明的市场战略。从恰当的细分市场里甄别出目标HCP并与之合作, 达成推广计划
• 充分了解所在地区和所负责区域的关键HCPs
• 更新客户数据
• 协调当地的“院内会议”
• 及时更新HCP的信息，根据计划进行拜访。
• 建立和维护和关键HCP的联系, 理解客户(医学)需求。
• 达成并保持公司关于拜访率、知识水平、能力、行为和个人形象方面的要求。
• 定期（每天）在ETMS 系统中报告拜访情况。
• 提供准确的报告，并且根据规定的流程联系直接主管。
• 提供给直接主管关于BMS 推广材料有效性的信息。.
• 通过参加培训、会议、和自学医学文献以发展和提高专业知识
• 和团队成员分享自己的知识和经验。
• 管理好专业设备和促销资料，确保完好。
岗位要求
• 具备医药，生命科学相关本科以上学历
• 熟悉当地医院的推广工作
• 1-3 年销售经验
• 有肿瘤经验者优先考虑
• 具备良好的人际沟通技巧，团队合作精神，能独立分析解决问题并在压力下工作。
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 a supportive culture, promoting global participation 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 an 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. 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: Senior Electrician, Fire System Specialist
Location: Devens, MA
Key Responsibilities
- Executes routine to intermediate/high level electrical maintenance activities on equipment used to support GMP manufacturing processes.
- Completes all work in accordance with CFRs, SOPs, job plans, and BMS policies. Participates/performs advanced troubleshooting and diagnostics in response to equipment failures with guidance of Lead Electrician.
- Performs scheduled maintenance and corrective work on site electrical systems and equipment with guidance of Lead Electrician, as applicable.
- Ensures all assigned work is completed within the assigned scheduled shift.
- Ensures that all maintenance documents are complete and accurate and submitted in a timely fashion.
- Participates in a detailed training program in order to develop one’s knowledge in the electrical maintenance field.
- Participates on the evaluation of electrical maintenance procedures and recommends and implements changes to optimize the maintenance program.
- Completes all required training within time limits assigned.
- Supports on-call response as needed.
- Experience working with 480-volt electrical systems.
- Performs various "Housekeeping" activities (i.e. keeping work areas clean, cleaning of equipment etc.).
- Supports and operates Addressable Computer operated Fire Alarm System involving hydrant, sprinkler and diesel engine operated Fire Pump Systems and associated devices ranging from Chemical response (Halon FM-200) systems to foam application equipment.
- Responsible for interaction with local town fire officials
Qualifications & Experience
- High School Diploma from a technical school or equivalent.
- A minimum of 6 years directly related experience on the electrical maintenance field for electrical systems, utilities and/or process equipment.
- Ability to interact and communicate directly with Operations staff to minimize impact to production activities.
- Basic knowledge of computer systems used in business, previous experience using automated work orders and job instructions desired.
“GPS_2025”
BMSBL, BMSBLDMA
#LI-Onsite
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 a supportive culture, promoting global participation 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 an 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. 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.
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.
The Reliability Engineer will help foster a Reliability Culture by establishing Reliability Centered Maintenance (RCM) procedures and initiatives for the Summit, NJ Manufacturing site. The Reliability Engineer will help systematically achieve adequate maintenance practices and asset lifecycle measures to help meet Engineering & Production Technical Services’ priorities, as well as comply with Global policies and goals. The Reliability Engineer will contribute to the growth and success of the Reliability Excellence program at the Summit site. The primary objective of the Reliability Engineer will be to ensure the reliability and efficiency of our manufacturing, laboratory, and facility equipment that supports the critical mission of delivering life-saving cell therapies to patients in need. This position reports to the Senior Manager, Reliability Engineering.
Shift Available:
Monday - Friday, Hybrid Day Shift, 8 a.m. - 5 p.m.
Responsibilities:
Knowledge of Reliability Centered Maintenance (RCM), Computerized Maintenance Management System (CMMS), and Predictive Maintenance (PdM) technology software.
Ability to prepare and present comprehensive reports with recommendations or needed changes.
Ability to be effective in both a team environment and an individual contributor role.
Knowledgeable in engineering principles related to instrumentation in a biopharmaceutical process.
Knowledge of regulatory, environmental, and cGMP requirements along with knowledge of manufacturing facilities, utility operations, and building maintenance operations.
Intermediate knowledge of electrical, mechanical, critical utilities such as compressed gas, HVAC systems, equipment functions, and maintenance practices.
Knowledge of typical CAR-T Cell Therapy upstream and downstream processing and support equipment.
Improves reliability of the systems, equipment, and operations by utilizing analytical, statistical tools and instrumentation.
Conducts and/or reviews failure modes and effects analysis (FMEA) to ensure proper maintenance tasks and intervals are established for all equipment in the RCM program to achieve the desired reliability.
Communicates with other departments (Manufacturing, QC, and Warehouse) to develop and meet reliability requirements to ensure strategic manufacturing goals are being met.
Prepares presentation slides to describe the status, benefits, and opportunities within RCM based recommendations and/or solutions.
Performs root cause failure analysis (RCFA) for chronic or critical equipment failures and identifies corrective actions necessary to increase future reliability.
Reviews maintenance equipment history to provide proactive solutions to potential problems affecting reliability and/or cost.
Ensures all new equipment meets or exceeds standards for reliability.
Works directly Maintenance group to provide guidance and decision making regarding the maintenance procedures and process to ensure the reliability goals for the plant are met.
Supports the execution of capital projects, when required. Ensures EHS and cGMP practices and regulations are considered in all activities related to the owned system, projects, maintenance, etc.
Supports predictive maintenance initiatives.
Provides support to other Engineering and Maintenance Department functions as required by plant needs and unplanned events.
Develops and follows strict Standard Operating Procedures (SOP’s) to ensure quality, and that compliant maintenance activities are completed in a timely manner.
Collaborating with cross-functional teams, assist in collecting and analyzing reliability data, equipment performance metrics, and maintenance records. This data-driven approach will help identify patterns, trends, and areas for improvement in the reliability of our processes.
Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced GMP environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
Familiarity with FDA / cGxP environments and associated compliance regulations
Knowledge & Skills:
A team player with the ability to influence others internally and externally in a matrixed organization.
Ability to connect and collaborate across internal and external organizations.
Effective in both a team environment and an individual contributor role.
Ability to manage and organize complex technical projects and familiarity with the manufacturing operations of large-scale production facilities as well as GMP experience.
Risk management, root cause Analysis, EHS principles, and asset management.
Adaptable to a fast paced, complex, and ever-changing business environment.
Advanced written and verbal communication skills. Advanced knowledge and proficiency of computerized inventory management systems (e.g., W.A.S.P., SAP, Blue Mountain RAM, Maximo, and Oracle).
Advanced proficiency in Microsoft Word, Outlook, PowerPoint, Project and Excel.
Intermediate/advanced knowledge of cGMP requirements.
Requires exceptional organizational and time management skills.
Basic Requirements:
Bachelor’s degree required in Engineering field or Life Sciences. An equivalent combination of education and experience will be considered.
7 years of GMP experience working within the pharmaceutical industry or other regulated industry.
Minimum of 2 years direct Engineering experience.
Preferred Requirements:
1-2 years of experience with cell and gene therapy.
Operational Excellence.
Reliability Engineering experience.
Working Conditions:
The incumbent may occasionally be working around hazardous materials to include chemical agents.
Minimum personnel protective equipment (safety shoes, safety glasses, hard hat) required.
Frequent writing and use of a keyboard.
Special gowning as defined and required in the manufacturing and other required areas.
Incumbent may be required to travel.
Incumbent may be required to work extended hours, or a modified work schedule as required for coverage of startup activities for future projects and support of ongoing 24/7 operations.
The incumbent must effectively communicate verbally and in writing.
The incumbent’s environment may be greasy, and the workspace may be confining with limited or restricted means for entry or exit.
The incumbent’s environment may have excessive noise.
BMSCART, #LI-Hybrid
GPS_2025
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 a supportive culture, promoting global participation 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 an 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. 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 Sr. Manager, IT Digital Plant Applications & Automation is an integral part of bringing RayzeBio’s innovative drug products to patients in need. In this role, you will report directly to the Exec. Director, IT and be primarily responsible implementing RayzeBio’s vision for growth and leading efforts to enable digital processes to achieve commercialization objectives at the site. The role will ensure the digital systems applications along with CSV for lab and process automation are enabled and maintained to successfully deliver novel Radiopharmaceutical technologies. You will work with lab & process automation, large corporate systems, small biotech systems, across all functions for the Indianapolis site(s). Additional responsibilities will include working with architectural and IT partners and specialty equipment manufacturers to achieve our technology and commercialization goals.
Job Responsibilities
Responsible for continuous operation and maintenance of IT, lab & process automation systems (including MES, LIMS, local manufacturing, quality control and quality management site IT systems) as well as associated site infrastructure.
Key partner for Engineering and process automation space.
Deliver to site service level management scope and process with IT groups and/or vendor managed services, i.e. Service Level Agreements (SLA’s), Disaster Recovery/Service Continuity, etc.
Work with service providers to deliver effective, innovative and stable solutions that meet the needs of the site.
Support site regulatory inspection readiness and data integrity initiatives.
Partner on new demand from the various site functions (Manufacturing Operations, Quality, Supply Chain, Manufacturing Science & Technology)
Identify key technology trends and how new technologies might be leveraged to provide better solutions to the manufacturing site
Support deployment of long-term (3 year) roadmaps identifying capabilities that have the greatest impact on business capabilities for the organization. Partnering and benchmarking with external sources.
Education and Experience:
Bachelors in Engineering, IT, Science field or equivalent
Minimum 10+ year’s relevant industry experience. Prior radiopharma experience is highly valued but not required.
Proven technical leadership and management experience.
Demonstrated experience implementing automation and digitization projects.
BS/MS Information Technology or similar degree or equivalent experience
Skills:
Ability to effectively communicate with both technical and non-technical team members.
Strong interpersonal skills, especially regarding:
Teamwork and collaboration
Client focus
Verbal and written communication
Knowledge of pharma IT Architecture and IT Infrastructure including Networks, Servers, HMIs, Printers, Scanners, Switches, Firewall rules, Domains, etc.
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
Strong technical and problem-solving skills and the ability to work independently.
Demonstrated success working in a high-performing, business results-driven environment.
Knowledge of Cybersecurity, patching and IT Life Cycle Management (LCM).
Understanding of computer system validation.
Physical Requirements:
Standard office environment coupled with GMP production and facility environment.
Must be willing to wear personal protective equipment (PPE) as required.
Must be comfortable working with radioactive materials.
#RayzeBio, #LI-Onsite, GPS_2025
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 a supportive culture, promoting global participation 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 an 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. 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 Sr. Manager, IT – GxP Computer Systems Validation & IT Process Lead is an integral part of bringing RayzeBio’s innovative drug products to patients in need. In this role, you will report directly to the Exec. Director, IT and be responsible to deliver on compliance and risk management for digital processes to achieve commercialization objectives at the site. You will work with lab & process automation, large corporate systems, small biotech systems, across all functions for the Indianapolis site(s). Additional responsibilities will include establishing and ensuring appropriate IT policies and processes while working with IT partners and specialty equipment manufacturers to achieve our technology and commercialization goals.
Job Responsibilities
Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams.
Ensure RayzeBio computer systems validated for intended use including Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, protocols.
Liaises with cross-functional SMEs in developing and promulgating the computer system validation methodology for radiopharma.
Participates actively with other groups to analyze and address process deficiencies. Work collaboratively with peers within various departments and Quality groups.
Provides validation subject matter expertise (SME) in the Digital Plant environment and contributes to multi-function teams, advises personnel on validation matters, and defends their work before regulatory agencies and auditors.
Provides CSV expertise and guidance.
Responsible for compliance with local and global SOPs during qualification.
Audit and Operational readiness for site.
Ensure complete understanding of corporate policies and procedures related to all aspects of computer system validation and applicable local processes and policies.
Change Management during qualification and sustaining.
Education and Experience/Skills:
Bachelors in Engineering, IT, Science field or equivalent
Minimum 10+ year’s relevant industry experience. Prior radiopharma experience is highly valued but not required.
Demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.
Understanding of, and experience with, supply chain, manufacturing and quality domains and supporting technology including Manufacturing systems (MES), Quality systems (LIMS, QMS), Supply chain systems (ERP), Process Automation and Historians.
Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, EudraLex Annex 11 and good documentation practices.
Demonstrated success working in a high-performing, business results-driven environment.
Physical Requirements:
Standard office environment coupled with GMP production and facility environment.
Must be willing to wear personal protective equipment (PPE) as required.
Must be comfortable working with radioactive materials.
#RayzeBio, #LI-Onsite, GPS_2025
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 a supportive culture, promoting global participation 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 an 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. 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.
Summary
The Validation Engineer II will help support the Radiopharmaceutical facility and GMP operations in Indianapolis. The Validation Engineer II will be responsible for the drafting and executing commissioning, qualification, and validation (CQV) documents and protocols which support the use of highly specialized facility, utility, analytical, and process equipment. The position will utilize a wide range of engineering disciplines to support the advancement from construction to clinical development and subsequent GMP commercial operations. Additional responsibilities may include the onboarding of new technologies, process development, GMP operations support, deviation investigation, CAPA management, continuous improvement projects, and future facility expansion projects.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
• Work with the project team and/or General Contractor as required to support the commissioning and validation of a 60,000 sq. ft. office, warehouse, and GMP Radiopharmaceutical production facility.
• Develop and implement the CQV strategies for the GMP spaces including but not limited to office, warehouse, development, quality control, sterility/microbiology, and GMP production areas.
• Work with consultant(s) as required to support the implementation and execution of the CQV program.
• Support the engineering, QC, and Operations team as required to improve and implement new processes
• Provide validation support for day-to-day development and GMP operations
• Provide engineering and operational support as required
• Expand expertise in additional areas of validation (process validation, QC assets, CSV, cleaning validation, etc)
• Own and manage a specific area of validation (i.e. process validation, QC assets, CSV, cleaning validation, etc)
• Apply technical knowledge and abilities to investigate manufacturing deviations
• Review data and documentation to support investigations
• Own and drive projects and continuous improvement efforts
• Draft GMP documentation including but not limited to SOP’s, Forms, Protocols, Technical Documents, Reports, Deviations, CAPAs, Change Controls and reports.
• Support Health Authority Inspections
• Maintain department KPIs related to performance
• Mentor and cross-train other team members
• Execute and provide support executing equipment and process validations as necessary.
Education and Experience
• BS or MS in scientific related field or equivalent work experience
• 2-5 years of experience in Radiopharmaceutical or injectable GMP manufacturing environment
• 2-5 years of validation experience within a GMP environment
Skills and Qualifications
• Good technical writing skill-set
• Solid understanding of regulatory guidelines for validation and risk management
• Must possess an independent mindset and tenacity
• Highly motivated and organized professional with strong interpersonal and communication skills.
• Proven experience working with teams in a GMP environment.
• Multi disciplined engineer with GMP experience
• Excellent professional ethics, integrity, and ability to maintain confidential information.
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 30 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials.
Work Environment
The noise level in the work environment is usually moderate.
#RayzeBio, #LI-Onsite, GPS_2025
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 a supportive culture, promoting global participation 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 an 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. 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 Director, Production is an integral part of bringing RayzeBio’s innovative drug products to patients in need. In this role, you will report directly to the Director, Operations and be primarily responsible for directing the day-to-day production activities to achieve corporate objectives at the site. The Director, Production will oversee and lead a team of production personnel to successfully deliver quality finished radiopharmaceutical products, on time, and in accordance with the production schedule. Additional responsibilities will include working with the Director, Operations in readying the site for scalability, as we work towards commercialization goals and expanded pipeline products.
Job Responsibilities
Provide leadership and direction to members of the production team including manager(s), supervisor(s), operator(s), and associate(s).
Collaborate with other functional areas for the triage of deviations, investigations, and CAPAs.
Represent production for the internal and external technical transfer of future projects.
Collaborate with the Project Management team to assure production schedule adherence.
Assist the Director, Operations in mentoring and development of key members of the production team.
Align with leadership on the Isotope Production team to ensure GMP compliance and synergy across all operations at the site.
Work with Quality, Validation, Engineer Services and Facility Engineering counterparts to successfully develop and implement novel radiopharmaceutical technologies.
Work with EM/Microbiology team to ensure contamination control strategies are followed and any OOT or OOS issues are addressed in a timely manner.
Develop and manage production related performance metrics.
Assist the Director, Operations with production-related budgeting.
Ensure production personnel comply with site EHS and Radiation Safety programs and promote a culture of safety.
Review, author and/or revise technical documents (SOPs, forms, deviations, etc.) as needed.
Up to 15% of travel required.
Education and Experience:
10+ years’ manufacturing experience in a cGMP injectable or Radiopharmaceutical environment is required.
Proven production leadership and management experience.
Demonstrated experience creating and managing production related metrics.
Working knowledge of industry related electronic systems (ERP, EQMS, etc.)
BS or MS Degree in a related technical field.
Skills and Qualifications:
Proven leadership and personnel management experience.
Strong knowledge of injectable and/or radiopharmaceutical drug product manufacturing.
Excellent professional ethics, integrity, and ability to maintain confidential information.
Organized and detail oriented.
Strong time management and organizational skills.
Strong interpersonal communication skills.
Motivated, adaptable, and able to work under pressure.
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 and climb stairs with or without accommodation. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.
#RayzeBio, GPS_2025
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 a supportive culture, promoting global participation 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 an 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. 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.
Summary
The Associate Director of Chemistry, Manufacturing & Controls (CMC) - Quality Assurance develops and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds in Development (radiopharmaceuticals). The emphasis of the position will be at the Indianapolis manufacturing facility and therefore, the incumbent must be located at the site. The incumbent will be responsible for multiple projects which may be at the Indianapolis site, San Diego, and/or CMOs.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
Member of CMC Development Teams providing Quality (QA) input from pre-clinical to end of product life cycle including NDA filing, other market filings, and post approval changes. Partners with technical SMEs to develop and approve the CMC strategy (DS, DP, and analytical strategy) for new drug candidates.
Responsible for change control management, for compound/product specific changes, through the product lifecycle to include impact assessments, tracking, and implementation. Also, as appropriate and compound/product specific, responsible Quality member for oversight and QA approver of all key Quality System deliverables associated with the drug development candidate including proactive Initiatives, Deviations, Investigations, CAPAs, and Complaints.
Review and approve compound/product specific analytical method life cycle documents (e.g., API and bulk drug product specifications, analytical test methods (including micro), and protocols/reports); including stability.
Work with CMC Teams to conduct compound/product specific risk assessments, as required, for all aspects of the drug development process. Responsible for communicating Quality risks within the Quality organization.
Collaborate with Regulatory to track/own Quality input for ongoing regulatory filings and updates to Health Authorities (e.g. IND/IMPD/BLA/NDA) including specifications, shelf-life extensions, country specific trial approvals, etc.
Performs other tasks as assigned (e.g., final Quality reviewer/approver of Quality events and/or GMP documentation, actively contributes to ongoing investigations as required).
Education and Experience
Minimum of B.S. degree, preferably in Chemistry, Biochemistry, or a similar Scientific field.
Ten plus years of hands-on biologics/sterile experience within a development/operations facility (manufacturing and/or analytical).
Prior experience in Quality is preferred.
An equivalent combination of education and experience may be substituted
Skills and Qualifications
Thorough knowledge of the Pharmaceutical Development processes as evidenced by bringing multiple INDs through to successful BLA/NDA approval. Knowledge of bulk biologic drug substance (monoclonal antibody, bispecific, etc.), parenteral (cold chain liquid/lyophilized form) drug product, cell/gene therapy product process development/manufacturing, and/or development/manufacturing of radiopharmaceuticals is required.
Recognized as a CMC expert, radiopharmaceuticals and/or biologics, with an ability to introduce best practices into the quality management systems.
Thorough understanding of cGMPs and regulatory requirements (e.g., FDA, EU, ICH).
Well-versed in relevant CMC area, with an ability to introduce Quality-relevant (phase appropriate) best practices into the CMC development processes.
Excellent investigational and QA problem-solving skills. Analytical mindset, with an ability to assess new situations to define and implement the appropriate QA action plan.
Ability to work independently, yet effectively in a team environment.
Superior attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
Teamwork oriented with the ability to work effectively across functional groups and teams to ensure requirements are met (e.g., early phase, late phase, regulatory).
Other proven competencies such as strategic thinker, influencer and negotiator are required.
Continuous improvement mindset is also required.
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 30 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials.
Work Environment
The noise level in the work environment is usually moderate. Work-related travel (outside of Indianapolis, Indiana) may be required up to 20% of working time (e.g., 10 weeks per year).
#RayzeBio, GPS_2025
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 a supportive culture, promoting global participation 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 an 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. 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.
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.
The Specialist or Senior Specialist, Data Integrity role is responsible for assisting with the implementation and management of Bristol Myers Squibb’s GMP Data Governance and Data Integrity program at the Summit West, NJ CAR T manufacturing facility. This includes implementing documentation and processes in support of the laboratories, manufacturing, and GMP support areas.
Shift Available:
Mon-Friday, Hybrid Day Shift, 8 a.m. - 5 p.m.
Responsibilities:
Responsible for executing data integrity documentation periodic reviews and performing risk monitoring of implemented systems across all sites to ensure continued compliance.
Responsible for assisting with the implementation of Global Data Integrity Processes at the site and ensuring that Global programs are implemented on-time.
Assist in ensuring local site activities are harmonized with Global DG/DI standards.
Provide feedback and support to GMP areas in scope during process improvement, while ensuring compliance with Global DG/DI policies and standards.
Responsible for ensuring systems at Summit West, NJ CAR T facilities comply with data life cycle requirements from initial data creation/recording to archival and decommissioning. This includes, but is not limited to, data management (e.g., data creation, data processing, review, reporting), data security, data traceability, process mapping, data backup/restore, electronic signature/electronic record linking and data audit trails.
Responsible for creating and executing data integrity assessments of new and existing systems including, but not limited to, manufacturing and laboratory systems to ensure compliance with regulatory requirements and company established requirements for data integrity.
Drive mitigation and remediation when data integrity gaps are identified.
Work with functional area SMEs at Summit West CAR T facility to ensure data risks are identified, remediated and prevented.
Seek out and recommend to management opportunities for increased data integrity program efficiencies and operational improvement through modifications to current systems, implementation of new systems and more efficient use of established systems.
Provide the GMP functions any updates regarding data integrity regulations that they may be impacted by.
Knowledge & Skills:
Must have familiarity with GMPs, Quality, and Data Integrity principles.
Must be familiar with system validation principles.
Must be familiar with the ALCOA+ principles and their application to both electronic and paper data.
Must be able to effectively interpret problems and communicate in an impactful manner to management and the group with clarity and a high level of accuracy.
Must be able to note data integrity impact in potential situations or issues and process science-based solutions across a majority of the job function.
Must provide guidance to other employees in the interpretation and correction of data integrity issues; across the Summit West, NJ Site’s CAR T Facility.
Must be able to critically review and author technical reports while effectively inputting and expressing Data Integrity principles.
Completes routine tasks with little to no supervision; Confident in making decisions in their subject matter area; Able to work proactively and identify opportunities for improvement.
Drives continuous improvement projects and improve efficiency and productivity within the group or project.
Support and lead cross functional project teams driving performance and results.
Coordinate projects with multiple functional areas. Able to recognize potential delays and notify management with proposed recommendations for resolution.
Strong project management skills with the ability to effectively communicate.
Builds and leverages relationships and provides advice internally within function and with global cross-functional teams.
Recognizes data integrity risks, develops contingency plans, ensures remediation efforts are driven to completion.
Able to fully interpret complex data Integrity results and situations within the data integrity team and articulate recommendations for resolution.
Must have familiarity with Computer System Validation and expertise with 21 part 11 requirements.
Basic Requirements:
Relevant college or university degree preferred. Equivalent combination of education and experience acceptable.
2- 3 years of GMP experience.
At least 2 years of Equipment and Computer Systems Validation experience (this is not a software role).
Data integrity.
Strong project management skills.
Working Conditions:
Work is performed in a typical office environment, with standard office equipment available and used.
Work is generally performed seated but may require standing and walking for up to 10% of the time.
Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
BMSCART, #LI-Hybrid
GPS_2025
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 a supportive culture, promoting global participation 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 an 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.
Corporate Affairs/Communications
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. 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
The Director of Federal Government Affairs is accountable for shaping health care policy to benefit patient access, affordability, and innovation. The Director will be responsible for initiating and executing comprehensive strategies around corporate priorities in Washington that will support BMS Enterprise priorities to bring innovative treatments to patients. The individual will be responsible for implementing an outreach strategy with Members of the United States Congress that align with BMS’ patient focused priority. The Director will monitor and analyze policies, trends and activities in Washington DC and will be responsible for communicating the business impact to key external and internal stakeholders and shaping legislation through engagement.
Key Responsibilities
- Represent BMS before the U.S. Congress, primarily with Senate Democrats, on company specific issues as well as issues of importance to the pharmaceutical industry.
- Collaborate with Corporate Affairs and US Policy & Government Affairs and Policy Communications (USPGAPC) and internal business partners to ensure an aligned approach and pursuit of Enterprise goals and priorities.
- Cultivate and maintain relationships with Members of Congress and their staff that will distinguish the company as a leader in the biopharmaceutical space while proactively advancing company objectives.
- Navigate the legislative and political environment and create (and implement) comprehensive strategies to address regulatory, legislative and policy issues that may impact BMS.
- Engage with external groups, including trade associations, to influence internal decisions and ensure alignment with BMS goals and priorities.
- Execute tactics around the company’s Political Action Committee focused on political giving strategy and internal growth.
- Provide updates and presentations to internal colleagues on developments in Washington, DC.
- Manage federal engagement by BMS consultants.
Qualifications & Experience
- A minimum of 8-10 years of experience/ service on Capitol Hill or relevant private sector professional experience
- Excellent verbal, analytical, written and interpersonal communication skills, particularly in interpreting and distilling complex information
- Excellent organizational and project management skills—demonstrated ability to independently manage multiple work streams
- Experience working with a variety of stakeholders, including trade associations and coalitions, and ability to proactively drive consensus.
- Ability to maintain good working relationships, internally and externally
- Travel as required
The starting compensation for this job is a range from [$200,000-$235,000], 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 Career Site (https://careers.bms.com/life-at-bms/)
- 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 a supportive culture, promoting global participation 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 an 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.