Principal Scientist Fill Finish and Single-Use Systems

Working with Us

Challenging. Meaningful. Life-changing. Those arent 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. Youll 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 : Squibb is seeking an enthusiastic self-driven individual to join its innovation focused multi-disciplinary team to lead the design and selection of single-use systems (SUS) that are suitable for the transition from development to commercial drug product manufacturing. This role will provide strategic direction to development teams on single-use technology selection and implementation to develop next-generation processes and technologies for manufacturing and cryopreserving adoptive T-cell role will provide scientific and engineering leadership to ensure compliant design qualification and lifecycle management of SUS used in drug product manufacturing formulation sterile filtration and filling ideal candidate has hands-on technical depth and proven experience supporting regulatory filings and validation activities in a large-scale biopharma or CDMO environment.

Key Responsibilities :

• Serve as a subject matter expert for aseptic fill finish operations including automated and semi-automated filling and sealing of bags and vials and support for filling line design validation and troubleshooting.
• Serve as development leader of SUS design specification and qualification for all DP unit operations in the clinical / pre-pivotal space and provide technical training and mentorship to process engineers and validation staff.
• Partner with suppliers to evaluate product contact materials for adsorption extractables / leachables particulates and compatibility with process sterilization validation and system integrity performance.
• Author and review technical documents including user requirement specifications design qualification IQ / OQ / PQ protocols risks assessments and tech transfer packages.
• Support supplier audits regulatory audits change controls investigations and CAPAs for SUS components impacting GMP manufacturing.
• Maintain awareness of emerging industry standards regulatory expectations and vendor technologies in fill finish and single use systems.

Qualifications & Experience :

standards

ASTM D543-06 TSE / BSE : EMA / 410 / 01 USP

ISO 11137 ISO 11737 USP

Annex 1 ICH Q9 and USP

Preferred Qualifications :

#LI-Onsite

BMSCART

GPS2025

If you come across a role that intrigues you but doesnt 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.

Compensation Overview :

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. 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 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 Years 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.

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 . Visit 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 : Protection

We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Required Experience :

Staff IC

Key Skills

Machine Learning,Python,Data Science,AI,R,Research Experience,Sensors,Drug Discovery,Research & Development,Natural Language Processing,Data Analysis Skills,Toxicology Experience

Employment Type : Full-Time

Experience : years

Vacancy : 1