Principal Scientist - Fill Finish and Single-Use Systems

Bristol Myers Squibb•Seattle, WA

2d•Onsite

About The Position

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 . Bristol-Myers 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 therapies. This 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 operations. The ideal candidate has hands-on technical depth, and proven experience supporting regulatory filings and validation activities in a large-scale biopharma or CDMO environment.

Requirements

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

Nice To Haves

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

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.

Benefits

Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.

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