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.

Role: Executive Director, CV/IMM Commercialization Finance

Location: Princeton, New Jersey
Geographic scope: Global

Direct reports: 3-5

Position Summary: Finance leadership to develop and execute Cardiovascular and Immunology strategy across the enterprise

Key Responsibilities/Leadership

• Partner closely with the Senior Vice President of Cardiovascular / Immunology Commercialization to drive strategy and execution of growth and legacy brands

• Play an active role in CV/IMM leadership team; lead development of financials and operating budget and plans to achieve it (incl. resource allocation decisions)

• Monitor business performance in concert with robust and insightful financial analysis, drive creation of realistic forecasts, challenge results as appropriate and develop recommendations to improve financial performance

• Establish a high level of credibility and manage strong working relationships with business partners and involved functions (Brand Marketing, Medical, Sales, BI&T, Value Access & Pricing, Supply Chain, Investor Relations)

• Identification and communication of the financial risks and opportunities and leadership of the execution or mitigation action plan

• Provide key input into pricing and contract decisions

• Maintain sound internal controls environment, ensure compliance with accounting requirements, laws and Company’s policies

• Lead and develop strong team of finance professionals located in Princeton Pike

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.

Our Analytical Strategy and Operations team creates transformative medicines of tomorrow based on the cutting-edge science of today. Working within Global Product Development and Supply this team uses state-of-the art technologies to develop, enable and execute analytical and CMC strategies that ensure safety, quality and efficacy of life-saving medicines administered to patients in clinical studies. Our team is involved at the earliest stages of Pharmaceutical and Biopharmaceutical product development through the successful commercial launch. As a member of our team, you will get the chance to play a pivotal role to positively impact patients’ lives while developing professionally to achieve your own career goals.

Position Summary:
 

The primary focus of the Laboratory Systems/Scientific Software Liaison role is to lead a team that will provide business ownership of select IT systems throughout their lifecycle.  These systems will support both GxP and non-GxP operations across all ASO sites.  In addition, this role will be the main conduit for relevant information with Product Development laboratory staff, ASO’s IT Business Partner, system owners & support teams, PDQ/ITQA/ITQS staff, portfolio/finance/PMO teams and management.  Finally, this role will be responsible for providing technical leadership to identify new or existing software capabilities that can assist ASO’s continuous improvement activities.

Role & Responsibilities:

• Manage a team of individuals to support the overall position responsibilities.
• Prioritize, manage, and delegate a portfolio of projects simultaneously across the entire team in support of a larger, departmental roadmap.  This responsibility includes all three key portfolio management indicators of budget, timeline, and scope.
• Maintain close communication with managers, stakeholders, and team members to keep apprised of system status, project status, impact on laboratory operations, and other relevant items.
• Collaborate with various cross functional colleagues (i.e., scientists, instrument vendors, QA, and IT colleagues) to evaluate opportunities for new digital capabilities in support of continuous improvement activities, setup and qualify new systems or upgrade existing systems for the ASO testing laboratories.
• Provide business ownership of select enterprise/stand alone systems throughout their lifecycle, which typically includes the following steps:  1) Analysis, Design, and System Selection; 2) Validation and Deployment Activities; 3) Operation; 4) Enhancement and Change Control; and 5) Retirement.
• Aggregate/manage information from various sources for owned systems to maintain an overall system status.  This information may include roadmap/obsolesce data, risk/issue lists, feature requests.
• Apply FDA CFR 251 Part 11/EU Annex 11 GAMP 5, and other applicable global health authority regulations to the lifecycle of computer systems to ensure they are in a validated state, supporting regulated business processes and computer software assurance.
• Follow SOPs and industry best practices.
• Serve as the ASO Computer System Validation (CSV) subject Matter Expert (SME).  Author and/or review validation deliverables including requirement and design specifications, summary reports, pre/post executed test scripts and procedures for supported systems.
• Support operational and compliance initiatives such as periodic reviews of systems, SOP updates, training materials, user requested enhancements, and system audit trail assessments.
• Assist in the preparation of assigned systems for audit readiness.  Facilitate audits and participate in the identification or resolution of CAPAs and other QEs.
• Develop standard operating procedures, work instructions, and other quality documents as needed to ensure the integrity of both the laboratory data collected and the systems used to collect the data.
• Stay abreast of current technologies, vendors, and platforms that could potentially benefit laboratory operations.
• Have the ability to define a path forward when there is no defined process.

Experience & Qualifications:

• BS or MS in scientific or IT discipline with minimum 10 years of hands-on laboratory-system experience (LIMS, Chromatography Data systems, or other relevant systems), with at least 3 years in an environment governed by GMP regulations or equivalent experience.
• Minimum 5 years direct experience managing teams, projects, and portfolios.
• Excellent oral and written communication skills in English.  In addition, above average competency with the Microsoft Office suite.
• Ability to perform in a highly matrixed organization structure.
• Possess expertise on Good Documentation and Good Testing Practices and solid understanding of cGMPs and Computer System Validations.
• Demonstrated experience installing, configuring, and supporting GMP systems and applications in lab environments. This includes instrument software applications.
• Demonstrated creative and innovative solution with regards to compliance in CSV and identifying areas of potential efficiency/productivity gains.
• Experience with electronic document management systems (e.g., Veeva platform, SharePoint etc.); application development and lifecycle management (e.g., ALM, ValGenesis, etc.)
• Experience with the complete system lifecycle for both regulated and non-regulated systems.
• Experience developing and delivering training for scientific software systems.

#LI-Hybrid

#GPSProdDev

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.

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.

We seek an enthusiastic and team-oriented scientist to join our Cheminformatics and Machine Learning Team. This individual will directly contribute to small molecule discovery projects that advance drug candidates – from hit identification through candidate nomination.

The successful candidate will perform key research activities, including:

• applying machine learning methods to drive chemical structure optimization within the context of therapeutic projects

• disseminating successful approaches across the computational chemistry department to enable uptake and impact on several discovery 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. Expertise in generative molecular design with applications to therapeutic projects would be beneficial. The successful candidate must have a sufficient understanding of chemistry and the ability to communicate with collaborative scientists from a broad array of backgrounds.

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:

• Ph.D. and no experience required, OR Master’s Degree with 3+ years of academic / industry experience, OR Bachelor’s Degree with 5+ years of academic / industry experience.

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 PyTorch, TensorFlow, Kera’s, Pandas, Scikit-Learn, DeepChem, RDKit or OEchem is essential.

• Experience in the critical assessment of experimental data. 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 in peer-reviewed scientific journals.

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.

PREREQUISITES

Bachelor’s degree in life sciences with a minimum of 5 years of clinical lab operations, quality and/or compliance; experience in pharma, biotech, CRO, or medical device preferred. MS in relevant life sciences field preferred. Previous lab supervisor experience preferred.

Strong knowledge in CLIA/CAP lab requirements and/or ISO13485 Quality Management System Regulation (QMSR).
Knowledge of global quality standards and regulations (GCP, GLP, GDP, and ICH GCP), and ALCOA+ principles.
Knowledge in various diagnostics technologies and platforms (e.g., PCR, NGS, IHC/pathology, Flow Cytometry, Mass Spectrometry, Imaging, etc.).
Experience in diagnostic lab operations, biomarker assay verification/validation, material qualification, and monitoring of quality controls.
Experience with preparation and readiness for audit/inspections, lab/site qualifications, and/or monitoring visits performed internally by Quality Assurance teams and/or externally by health authorities, diagnostics partners, or monitoring personnel.
Experience in using Quality Management Systems, Document Control systems, and quality/compliance improvement tools and techniques.
Effective use of Microsoft Office suite, SharePoint, and Adobe Acrobat.
Demonstrates strong communication skills, cross-functional collaboration skills, and a cross-cultural awareness.
Demonstrates strong organizational, analytical, planning, decision-making skills.
Ability to work at a high level both independently and within cross-functional teams.
Ability to work in a fast-paced environment with attention to detail and delivering high quality results.
 

Summary/Scope

Bristol Myers Squibb (BMS) is a global biopharmaceutical company engaged primarily in the discovery, development, and commercialization of novel therapies for the treatment of human diseases.

The Lab Planning and Execution group is part of the Translational Sciences (TS) team with Translational Medicine (TM). TS leads internal and external diagnostic research & development activities to support multiple disease areas of interest including hematological malignancies, inflammatory disease programs, neuroscience, cardiovascular, fibrosis, and solid tumor indications. The TS team integrates scientific and business insights of multiple functions to provide innovative solutions that will make precision medicine a reality for the patients and health care providers we serve. 

This position reports to the Director, Lab Planning and Execution.  He/she is accountable for the delivery of robust and compliant lab services across all TM labs, including the TM CLIA Laboratory, in support of the BMS pipeline. This position, Manager, will support various TS laboratory heads and scientists to ensure GCP compliance is met based on the intended use of each lab. The employee will also be required to work with cross-functional stakeholders to ensure compliance and audit/inspection readiness of for the TM CLIA Laboratory.

Roles and responsibilities include, but are not limited to, the following:

• Serves as a GCP Subject Matter Expert for TS teams and TM labs, providing independent and objective consultation in support of clinical trial activities and in line with current best practice.
• Ensures that record keeping is complete, and records are maintained appropriately by lab staff; includes ensuring the requisite standards are applied based on the intended use of the lab.
• Conducts regular internal diligence reviews to promote compliance in the labs.
• Responsible for documenting corrective actions and developing plans to prevent future errors and improve processes.
• Prepares reports for periodic reviews of key quality and performance indicators across the TM labs.
• Ensures that TM lab employees’ qualifications and job descriptions are maintained on the required basis. 
• Strives to continuously improve lab quality and productivity simultaneously.
• May manage the Training Curricula for the organization; optimize assignment of the appropriate training to the appropriate individuals; provide metrics on compliance and identifies ways to improve adherence to training plans.
• Identifies and reports compliance issues to management with recommendation for resolution.
• As required, run reports and conduct data analysis to support monitoring of key compliance performance indicators; support developing and reporting to management utilizing technical knowledge and laboratory experience; support preparation of compliance data for the monthly and/or quarterly presentations.
• Ensures compliance with CLIA/CAP laboratory licensing/permitting, accreditation, regulatory standards, and policies by providing leadership and guidance to staff to ensure that policies, processes, and procedures are established, current, and adhered to by all laboratory staff.
• Leads and maintains Out of State clinical lab licensing and permitting for CLIA lab.
• Ensures and maintains a state of audit/inspection readiness; performs compliance walkthroughs with CLIA management and supervisors, TM lab staff, Quality Assurance, and Lab Operations as part of audit/inspection readiness activities to ensure labs are in an audit/inspection ready state.
• Leads the implementation, execution, and improvement of the internal and external audit/inspection process for CLIA lab; coordinate front room/ back room activities; support generation of audit/inspection responses and observation resolution through CAPA.
• Drive lab and site compliance to regulatory, enterprise, and global requirements through building positive cross-functional relationships, to meet unified business objectives.
• May support CLIA supervisors with oversight of, proficiency testing programs and external assessments; competency assessments; LIMS and procedural training; and other compliance associated processes.
• Support maintenance of CLIA lab QMS and document management.
• Assure that BMS values are demonstrated in all aspects of individual actions and team interactions.

Skills/Knowledge Required:

• Bachelor’s degree in in life sciences, Master’s degree in relevant life sciences field preferred.
• A minimum of 5 years of clinical lab operations, quality and/or compliance experience required; experience in pharma, biotech, CRO, or medical device preferred.
• Strong knowledge in CLIA/CAP lab requirements and/or ISO13485 Quality Management System Regulation (QMSR).
• Knowledge of global quality standards and regulations (GCP, GLP, GDP, and ICH GCP); knowledge of ALCOA+ principles.
• Knowledge in various diagnostic technologies and platforms (e.g., PCR, NGS, IHC/pathology, Flow Cytometry, Mass Spectrometry, Imaging, etc.).
• Experience in diagnostic lab operations, biomarker assay verification/validation, material qualification, and monitoring of quality controls.
• Experience with preparation and readiness for audit/inspections/qualification visits performed internally by Quality Assurance teams and/or externally by health authorities, diagnostics partners, or monitoring personnel.
• Experience in using quality management systems, document control systems, and quality/compliance improvement tools and techniques.
• Effective use of Microsoft Office suite, SharePoint, and Adobe Acrobat.
• Demonstrates strong communication skills, cross-functional collaboration skills, and a cross-cultural awareness.
• Demonstrates strong organizational, analytical, planning, decision-making skills.
• Ability to work at a high level both independently and within cross-functional teams.
• Ability to work in a fast-paced environment with attention to detail and delivering high quality results.

Skills/Knowledge Desired:

• Experience in audit/inspection readiness timeline management, mock inspections, and interview preparation; conducting internal audits (self-inspection), serving in critical front room/ back room roles for external audits/inspections.
• Experience in CAPA, investigations, RCA, deviations, and nonconformance.
• Experience as a CLIA lab supervisor.
• Ability to use tools and information technology systems for project management (e.g., Smartsheets, MS Project, MS Teams, MS Visio), data visualization and/or statistical analysis (e.g., Spotfire, Tableau, JMP), or generative AI (e.g., ChatGPT).
• Knowledge of Design Control (21 CFR 820), ISO13845, In Vitro Diagnostic Medical Device Regulation (IVDR), and New York State clinical laboratory requirements.
• Experience in leading Out of State clinical lab licensing and permitting.
• Experience in using a regulated LIMS.
• Knowledge in drug development, diagnostic development, companion diagnostics, and/or translational development processes.
• Experience in working with diagnostics and biomarker assays being utilized for exploratory purposes and investigational use only.
• Experience in biospecimen lifecycle management, data management activities, and/or oversight and monitoring of laboratories for clinical studies.

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.

The successful candidate will be a strategic thinker and a proactive leader, capable of driving continuous improvement and ensuring the effective management of projects and processes. This role offers the opportunity to make a significant impact on the ECF team and contribute to the broader success of Bristol Myers Squibb.

Position Summary

The Senior Manager, Reporting, Process & Project Management at Bristol Myers Squibb plays a pivotal role in supporting the Enterprise Contract Facilitation (ECF) Team. This position is essential for assisting the Head of ECF and the Director, International Pod Lead in data management, reporting, and performance tracking efforts. The role involves documenting and scoring performance against ECF’s priorities and objectives, including reporting on data gathering requirements, goals, priorities, and documenting key performance indicators (KPIs) for the ECF portfolio.

Additionally, this role supports ECF and special reporting projects for the Executive Director, Strategy & Operations Law, by providing accurate data and insightful reporting to generate and realize value opportunities. The position also focuses on enhancing process and Ways of Working effectiveness, managing projects aimed at growing and stabilizing the ECF team. By strategically and efficiently supporting ECF activities, the role identifies areas for continuous improvement and implements efficiencies where applicable. The successful candidate will possess a solid understanding of pharmaceutical contracting and project management, strong communication skills, and the ability to work effectively in a dynamic environment.

Key Responsibilities and Accountabilities include, but are not limited to:

Contract Process, Strategy & Projects:

• Support the development of goals and objectives for the ECF team, ensuring alignment with the overall Law strategy, including conducting annual reviews and providing regular updates throughout the year.

• Gather inputs from key stakeholders in ECF, Global Procurement, the Law Department, and the Business to develop a multi-year strategic roadmap, incorporating key capability development programs and a digital & technology roadmap.

• Continuously seek opportunities to improve ECF processes, policies, and procedures to enhance overall effectiveness and efficiency.

• Manage projects aimed at growing and stabilizing the ECF team, expanding its scope, and fostering collaboration with other stakeholders.

• Undertake additional activities and projects as required by the Head of ECF and the Director, International Pod Lead.

Data and Reporting:

• Provide comprehensive support in data management and reporting for the ECF team, ensuring accurate documentation of performance metrics and alignment with ECF’s strategic priorities and objectives.

• Oversee the documentation and scoring of performance against established goals, priorities, and KPIs, ensuring transparency and accountability within the ECF portfolio.

• Support special reporting projects for the Executive Director, Strategy & Operations Law, by delivering precise data and insightful reporting to identify and realize value opportunities.

Process Improvement and Strategic Support:

• Drive process and Ways of Working effectiveness and improvement initiatives, managing projects aimed at growing and stabilizing the ECF team.

• Contribute to the strategic and efficient execution of ECF activities, identifying areas for continuous improvement and implementing efficiencies where applicable.

• Support and presenet with Head of ECF and International Director to Senior Leadership Meetings in Procurement, Legal and possibly the business. Assist Head of ECF and International Director with creating PowerPoint slides that are high-level and able to convey important messages and metrics clearly.

Reporting, Analysis, and Stakeholder Management:

• Analyze performance trends, proactively identify potential shortfalls and risks, and make fact-based recommendations to manage these risks.

• Manage ongoing reporting and monitoring of key metrics, including liaising with key stakeholders in ECF, Global Procurement, the Law Department, and the Business for progress updates.

• Report on data gathering requirements, goals, priorities, and document key performance indicators (KPIs).

• Pull data from multiple systems and convert raw data into an understandable form to analyze turnaround times for various phases of the contracting process.

• Create performance reports, SLA tracking, and other contractual deliverables for performance management, utilizing extensive data from multiple sources.

• Design and implement strategic insights to achieve ambitious business goals and foster continuous improvement across diverse markets.

• Leverage versatile expertise to deliver innovative solutions and drive sustainable growth in complex business environments.

• Formulate and analyze insightful reports to empower data-driven decision-making and illuminate key performance indicators.

• This role will support and enable the development and implementation of all initiatives within the ECF multi-year functional strategic roadmap that will focus on analytics capabilities.

Internal/External Stakeholders:  

• Executive Director, Strategy & Operations Law

• Assistant General Counsel, Strategic Corporate Transactions

• Strategic Corporate Transaction Attorneys

• Global Procurement & Leadership

• Business Requesters & Leadership

Minimum Qualifications & Experience

• B.S./B.A. degree required MBA/MS preferred

• Minimum of 5-8 years of experience in purchasing and/or contracting data reporting.

• Strong data analysis skills with expertise in Microsoft Excel, including vlookup, macros, pivot tables, and data visualization.

• Excellent communication and stakeholder management skills, with demonstrated ability to partner with and manage internal stakeholders, including senior leaders, within a highly matrixed organization.

• Ability to work effectively in a dynamic and fast-paced environment.

• Expertise in data, digital, and analytics, with a strong understanding of technology and infrastructure.

• Business process and data expertise, with the ability to map and understand processes and efficiencies.

• Project and stakeholder management experience, with a focus on strategic planning and organization.

• Future-oriented growth mindset, with a focus on continuous improvement and innovation, strategic thinking a must.

• Proficient in Microsoft PowerPoint for creating professional presentations.

• Expertise in procurement processes, contract and supplier analysis and management, financial analysis, market analysis, supplier diversity, and integrated supply chain.

• Strong understanding of data analytics, category management, project management, and performance management.

Preferred Qualifications

• Strong understanding of pharmaceutical contracting and project management

• Professional certifications (e.g. CPM, CPIM).

• 4 years Pharmaceutical Procurement experience

• Membership in Professional Associations, e.g. ISM

• Experience with procurement contracts, preferably within the pharma/biotech/CRO industry.

• Proficiency in contracting processes and procurement systems (such as Ariba, Icertis).

#-LI-Hybrid

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.

Title: Senior Specialist, Facilities and Utilities Commissioning & Qualification

Location: Warren, NJ

The C&Q Senior Specialist supports the successful operation of facilities, laboratories, and business functions at multi‐use sites through interaction with internal team members and peer‐level customers as well as external service providers.  The position focus is on providing technical expertise and decision making while ensuring end-to-end and timely completion of Facilities and Utilities projects and ongoing work activities of low to moderate complexity, individually and with support of others.  The incumbent spends most of their time on individual work.  The incumbent may recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit.  The incumbent in this role works with entry, junior, and experienced level professionals to accomplish daily tasks and short‐term projects according to established policies and procedures.

Key Responsibilities

• Author, review, approve, and execute test protocols, plans, summary reports, protocol deviations, and other validation deliverables as required.
• Administer change control activities and corrective and preventive actions.
• Author, review, and approve SOPs, work practices, and other procedural documents.
• Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.
• Serve as a Subject Matter Expert for change controls, investigations, CAPAs, and deviations as applicable.
• Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
• Provides technical support and guidance on equipment commissioning and qualification.  Interfaces with customers to ensure all expectations are met.
• Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
• Ensures timely completion of facilities, utilities, and equipment commissioning and qualification projects, individually and/or with support of colleagues.
• Develops an effective mechanism for communicating the current status of all ECQ projects to affected stakeholders.
• Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.
• Ensures manufacturing and laboratory equipment, facilities, and utilities are maintained in compliance with GMP and other BMS standards and regulations.
• Acts as equipment, facilities, and utilities commissioning and qualification Subject Matter Expert in internal and regulatory audits.

Qualifications & Experience:

• BS in Engineering required. Must be able to read and understand construction and mechanical drawings and P&IDs.
• Minimum of 6 years of experience in FDA-regulated industry.
• Minimum of 4 years of experience developing and executing facility and utility qualifications.

• Advanced knowledge of cGMP pertaining to pharmaceutical facilities, utilities, and equipment.
• Strong background and experience in laboratory and manufacturing operations with advanced knowledge of pharmaceutical manufacturing and utilities that support cell therapy clinical manufacturing.
• Advanced knowledge of commissioning and qualification of clean manufacturing facilities, material pass-throughs, AHUs, compressed air, carbon dioxide, and process air systems.
• Excellent technical writing skills and proficiency with Microsoft Suite and Word formatting functions; detail oriented and technically accurate author and reviewer of documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document quality.
• Excellent interpersonal/communication skills and experience dealing with a diverse workforce.
• Strong multi‐tasking ability in conjunction with proven organizational skills.  Ability to organize assigned tasks in a fast-paced environment and concurrently monitor tasks and assignments with others that may impact timely completion. Independently and effectively manage multiple tasks and activities simultaneously.
• Working knowledge of scheduling software and systems, and inventory management systems.
• Ability to create and analyze meaningful metrics.
• Experience interacting with external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions is preferred.
• Preferred experience commissioning and qualifying liquid nitrogen supply systems, DI Water, autoclaves, isolators, and filling and capping equipment.
• Strongly preferred experience designing and performing airflow visualization studies and executing temperature/humidity mapping qualifications for controlled storage areas.

#LI-Onsite

BMSCART

VETERAN

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.

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: Manager, Cleaning Validation, Validation Engineering

Location: Devens, MA

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

Manage the development and maintenance of the cleaning validation and changeover cleaning verification program elements for a fully automated, multi-product, biologics manufacturing facility to assure readiness for intended use and to meet all policy and compliance requirements.

Key Responsibilities

• Responsible for implementing the design, implementation and maintenance of a robust cleaning validation lifecycle for process equipment and systems, that includes a bench-scale cleaning program, an efficient cleaning validation philosophy, a cleaning monitoring program, and a cleaning verification changeover program for a fully automated, multi-product biologics manufacturing facility.
• Establish and implement the cleaning validation philosophies and master plans required to drive the cleaning validation lifecycle.
• Responsibilities include oversight of cleaning validation lifecycle maintenance that includes establishment of validation document hierarchy, tracking execution work arising from change controls, shutdown/changeover management related to validation, and management of the revalidation and cleaning monitoring programs.
• Responsible for regulatory inspection readiness and guidance to ensure cleaning validation and cleaning verification changeover philosophies are well understood.
• Manage multiple projects.
• Work collaboratively with peers within the Validation Execution function, Manufacturing Systems, Information Technology, Manufacturing, Manufacturing Engineering and Quality
• Effectively manage workload to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
• Ensure alignment with BMS directives and industry guidelines on cleaning validation and quality engineering.
• Leads and/or executes validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing validation lifecycle programs. This individual works at the highest level and collaborates with Quality Assurance, to establish appropriate, risk-based validation methodologies.
• Provides validation subject matter expertise (SME) and contributes to multi-function teams, advises operations on cleaning validation matters.
• Supports internal compliance and/or efficiency improvement efforts within department for more complex processes.

Qualifications & Experience

• Knowledge of Engineering and Quality Assurance generally attained through studies resulting in a B.S., in engineering, a related discipline, or its equivalent and applicable industry experience.
• A minimum of 6 years relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
• Experience with process equipment and system qualification, steaming/sterilization qualification, cleaning validation, and multi-product changeover requirements.

• Experience in designing cleaning program elements, steaming/sterilization program elements, bench-scale studies to support cleaning and implementation of supporting quality systems required to manage the cleaning cycles and changeover program of a fully automated, multi-product, biologics manufacturing facility.
• Experience in establishing site and program validation strategies that are aligned with current industry mindsets.
• Understanding of the US and ex-US regulatory requirements for licensure of a multi-product biopharmaceutical facility.
  • Understanding of lean principles and establishment of effective process metrics is preferred.
  • Project management, communication, and technical writing skills are required.
  • Possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.
  • Working knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the technical acumen to work and manage within a regulatory environment.

• Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics manufacturing.
  • Ability to develop and apply new and innovative approaches to projects and processes.
  • Must be able to influence others.
  • Demonstrated emotional intelligence required to inspire and influence the behaviors and performance of others, as well as for conflict management.
  • The flexibility required to constructively lead and encourage peers and team members to drive results in a changing 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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.

__________________________________________________________________________

The following positions will require the employees to work with chemical, radiological, or biological agents that may be hazardous to health if mishandled (including Agents which may potentially affect reproduction or the fetus).  Employees will be required to follow all safety procedures and use personal protective clothing/Equipment where specified.  Inquires for further information should be directed to the hiring manager.

__________________________________________________________________________

Permanent Position – Process Engineering Mechanic – 51I – CSO

Shift: 7 AM - 3:30 PM EST         

Site: New Brunswick, NJ

Bldg # 115 (excluded)

Rate: $45.00 / hour

JOB FUNCTION:

• Performs preventative maintenance on pharmaceutical process equipment including tablet presses, tablet coaters, roller compactors, fluid bed processors, blenders, mills, and encapsulation machines.  Continuous manufacturing experience a plus.
• Diagnose and/or repair mechanical, electrical, pneumatic, hydraulic, and/or PLC issues to minimize manufacturing downtime.
• Consult and coordinate with equipment vendors as necessary to complete maintenance activities, order parts, and optimize performance.
• Perform work with strict compliance to all BMS operating and safety SOPs, cGMPs, Good Documentation Practices, and OSHA regulations.
• Assists in the development of detailed job plans for PM work and equipment assembly, operation, and cleaning SOPs.
• Provides feedback to management and recommends improvements to optimize performance, increase safety, and compliance with procedures/regulations.
• Assists Facility Maintenance with upkeep of the OSD manufacturing facility.
• Utilize the Computerized Maintenance Management System (Maximo) and other computer programs to complete job tasks.
• May assist manufacturing personnel with equipment operation during production as required.
• Must be able to meet the requirements for respirator and/or appropriate use certification as working condition around potent compounds may occur.
• Must be mechanical and electrically inclined with ability to read equipment drawings, electrical schematics, and P&IDs.
• Contributes to and supports an environment that fosters diversity, inclusion, engagement, and open communication.
• Performs other functions as required or assigned.

EDUCATION REQUIREMENTS:

• High School diploma or equivalent.
• 2-year associate’s degree and/or successful completion of a vocational-tech program directly related to Industrial Maintenance from an accredited technical school/college is preferred.
• 5 years of experience in a cGMP pharmaceutical manufacturing/technical environment or substantial familiarity of pharmaceutical manufacturing equipment in a cGMP solid dose environment.
• Current, valid driver’s license.
• Must have basic computer skills (e.g. Microsoft Office, email, internet)
• Knowledge of a Computerized Maintenance Management System (CMMS), i.e.: Maximo is preferred.
• Demonstrated ability to effectively troubleshoot, plan work and anticipate potential problems and take appropriate actions.
• Demonstrated ability to remove defective parts by dismantling equipment, using hoists, cranes, and hand and power tools.
• Demonstrated ability to determine changes in dimensional requirements of parts by inspecting used parts, using rules, calipers, micrometers, and other measuring instruments.

WORKING CONDITIONS:

The position will require the employee to work in areas where chemical, radiological and biological agents that may be hazardous to health if mishandled (including agents which may potentially affect development of the fetus). Assignments may be executed in all NBR R&D Manufacturing facilities interchangeably. Disagreeable conditions including odors, heat, cold, noise, etc. may be experienced. In addition, candidates:

• Ability to work overtime when warranted.
• Must be willing and able to wear all required PPE (personal protective equipment) including protective garments and respirators.
• Must be willing and able to work at elevated heights (e.g. elevated walkways, grating, platforms, ladders, scaffolding, etc.) and within confined spaces where applicable.
• Ability to perform physically demanding tasks repetitively for extended periods of time (i.e. lifting (up to 35 pounds), walking, climbing, stooping, standing, pushing and/or pulling) with or without reasonable accommodation.

_____________________________________________________________________________

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.