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:

• PhD in Chemical or Mechanical Engineering Life Sciences Materials Sciences or related discipline with 3-5 years of industry experience preferred
• or BS/MS with equivalent experience in regulated biopharmaceutical manufacturing MSAT or validation engineering
• Excellent communication and interpersonal skills including externally client facing as the single point of contact with suppliers to communicate user requirements and provide guidance to address gaps in supplier capabilities and/or technologies
• Expertise in small batch fill/finish process development including single use kit design primary container selection and design filling parameter optimization sealing parameter optimization access devices and clinical administration options
• Expertise in fill/finish testing methods including sterile filtration validation residual seal force and container closure integrity testing to meet USP <1207> standards
• Experience in polymer/material science or polymer manufacturing to inform materials risk assessments
• Familiar with Cell Therapy SUS sub-components (E.g. hose barbs boat ports oetiker clamps etc.) and material types (e.g. Tepoflex (TPE) silicone PVC fluoropolymers polyethylene (PE) etc.) and characteristics of these plastics and polymers including biocompatibility process suitability extractables/leachables and connections to enable aseptic processing
• Working knowledge of single-use and consumable compliance standards including ASTM F-2097 USP<87> ASTM D543-06 TSE/BSE: EMA/410/01 USP<788> ISO 11137 ISO 11737 USP <665>/<1665> Annex 1 ICH Q9 and USP<85>
• Understanding of the regulatory and compliance requirements for raw materials and SUS/SUT used in CGT manufacturing
• Strong understanding of cGMP principles 21 CFR and ICH Guideline compliance
• Self-motivated individual with demonstrated ability to lead and support highly cross-functional teams.
• Demonstrated ability to analyze technical data and support the design of experiments
• Strong documentation skills including authorship of technical reports and regulatory submissions

Preferred Qualifications:

• Experience with cryopreservation and ultra-low temperature storage of containers
• Experience with mammalian and/or T-cell closed culture operations and cell handling/fluidics
• Experience specifying and designing single-use components and assemblies for pharmaceutical and/or cell therapy applications
• Experience with process equipment design qualification and implementation preferably with single-use systems at a biopharmaceutical company or bioprocessing supplier
• Experience with use of CAD software for development of component and assembly schematics and/or drawings
• Membership and/or participation in industry forums focused on the standardization of SUS requirements design and testing practices

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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.

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.

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