Analytical Validation and Knowledge Management Scientist

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 .

Key Responsibilities Responsible for creating and driving analytical change controls for changes to global test methods or regulatory filings.

Responsible for creating and driving analytical method transfers and/or validations in GMP Quality Control labs, both internally and externally — including generation of protocols, reports, acceptance criteria, co-ordination of execution, sample/material shipments, project management, and provision of program updates to leadership.

Responsible for trending of validation/tech transfer raw data.

Responsible for statistical requirements linked to method transfer/validation reports.

Data verification of analytical data packages.

Protocol and report writing through templates/AI tools.

Responsible for facilitating review and approval meetings, problem-solving key issues, and effectively managing communications with key stakeholders linked to protocols and reports.

Responsible for collecting review feedback and resolving comments and questions.

Responsible for projecting and communicating stakeholder actions and timing.

Responsible for escalating any deficiencies in protocols/reports that cannot be resolved with the working team, and escalating risk to meeting completion dates and program deliverables.

Synthesize feedback from SMEs/analytical teams to identify and document issues relative to current and future processes.

Responsible for facilitating the intake of data (timelines, deliverables, knowledge, etc.) related to early asset projects and maintaining that data in appropriate data management repositories.

Function as an SME to support knowledge management, program timelines, and reporting utilizing Microsoft Office Tools, SharePoint sites, and related data management software, including PowerBI.

Responsible for document management, including formatting and upload of relevant analytical documents such as specifications, methods, protocols, and reports to EDS systems such as GTS and BMS-Docs.

Responsible for maintenance of project deliverables and program timelines, engaging internal and external stakeholders for updates and communicating changes through appropriate channels, including periodic dashboards, and escalating risks to meeting pre-defined deliverables and timelines.

Utilize project management software to update task statuses, assign tasks, set deadlines, and establish automated reminders; organize document repositories to ensure all team members have access to the latest files, coordinate across different time zones.

Schedule and coordinate team calendars, meetings, and activities across different time zones.

Foster compliance with GMPs and BMS Policies and Procedures.

Work closely with the Global QCEAS team on associated data, systems, and processes for BMS products.

Responsible for assessment of data (including timelines, deliverables, and reports) against pre-defined criteria.

Responsible for supporting strategic initiatives and continuous improvement projects related to QC Strategy and Analytical Sciences.

Develop trusting, open, and collaborative partnerships while ensuring stakeholders have a clear understanding of BMS's QCEAS procedural requirements.

Education Minimum of a Bachelor's degree in Biological Sciences, Chemistry, or a related life science field.

Experience & Skills A minimum of 5 years of experience in the Biopharm/Pharmaceutical industry, with cross-functional experience in one or more areas (e.g., research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT).

Prior employment at a pharmaceutical manufacturing site in a Quality or operations role is an advantage.

Fluent in English, with proven professional working proficiency in reading, writing, and speaking.

Knowledge and experience in commercial analytical method lifecycle, including familiarity with analytical control strategies, drug development timelines, test methods, specifications, reference standards, and critical reagents.

Demonstrated experience with analytical methods (in-process, release, and stability) used in late stage/commercial products, including health authority regulations.

Experience in analytical change controls in a GMP environment; previous experience in a QC laboratory is highly desirable.

In-depth knowledge of Quality Management Systems (QMS) relating to laboratory operations.

Proficiency in cGMP/GDP regulations and a thorough understanding of company policies and regulatory requirements as they relate to the management and documentation of product quality.

Experience with Microsoft Office Suite (including PowerBI and SharePoint); strong project management software skills.

Strong ability to communicate effectively and work collaboratively in a matrixed organization.

Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.

Sets and maintains high performance standards; pays close attention to detail, accuracy, and completeness.

Adapts to changing work environments, work priorities, and organizational needs.

Plans and organizes tasks and responsibilities to achieve objectives; sets priorities and schedules activities.

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.

Supporting People with Disabilities 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.

Candidate Rights 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/

Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

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

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1602021 : Analytical Validation and Knowledge Management Scientist