Bristol Myers Squibb · 1 month ago
Principal Scientist - Fill Finish and Single-Use Systems
Seattle 400 Dexter - WA - US
Full-time
Onsite
Senior Level, Lead/Staff
$144K/yr - $175K/yr
3+ years expBristol 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 that are suitable for the transition from development to commercial drug product manufacturing. This role will provide strategic direction on single-use technology selection and implementation for manufacturing and cryopreserving adoptive T-cell therapies, ensuring compliant design and lifecycle management of systems used in drug product manufacturing.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
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
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
Benefits
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
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2025 (247)
2024 (278)
2023 (231)
2022 (180)
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2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
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