Job SummaryWe are looking for an Upstream Manufacturing Manager to lead GMP upstream manufacturing operations across mammalian and microbial production platforms. This role is responsible for overseeing daily manufacturing activities, ensuring compliance with established processes and standards, and delivering safe, reliable, and efficient execution of clinical and commercial production campaigns.
The Upstream Manufacturing Manager provides leadership and direction to manufacturing teams, ensuring operational readiness, schedule adherence, and continuous improvement while supporting technology transfer, process implementation, and commercial manufacturing activities.
About the Manufacturing TeamYou'll join a Manufacturing organization responsible for the production of biologics across multiple modalities and stages of development. The team partners closely with Quality, MSAT, Engineering, Supply Chain, and other operational functions to ensure safe, compliant, and efficient manufacturing operations that support both clinical and commercial programs.
Key Responsibilities- Lead upstream manufacturing operations across mammalian and microbial processes.
- Monitor and improve compliance with quality systems, safety procedures, and company policies.
- Determine production priorities, staffing requirements, and shift schedules to support manufacturing objectives.
- Ensure effective communication and operational alignment across shifts through the Daily Management System (DMS).
- Monitor manufacturing operations to ensure compliance with SOPs, batch records, and GMP requirements.
- Identify, address, and prevent operational issues that may impact safety, quality, reliability, identity, or purity (SQRIP).
- Train, coach, and mentor manufacturing associates and supervisors.
- Review and approve manufacturing documentation.
- Manage team performance, goal setting, development planning, and performance reviews.
- Coordinate resources and activities across manufacturing areas to meet production goals and timelines.
- Ensure equipment, personnel, materials, and manufacturing suites are prepared for scheduled operations.
- Support technology transfer, process implementation, PPQ, clinical manufacturing, and commercial manufacturing activities.
- Monitor production performance, equipment availability, schedule adherence, and operational risks.
- Drive continuous improvement initiatives focused on safety, quality, productivity, reliability, and cost.
- Establish and maintain manufacturing KPIs and performance metrics.
Skills- Demonstrated knowledge of upstream biologics manufacturing, including mammalian cell culture and/or microbial fermentation.
- Experience supporting stainless steel and/or single-use bioreactor systems, harvest operations, aseptic processing, and CIP/SIP systems.
- Ability to lead manufacturing operations across multiple production areas, shifts, and modalities.
- Strong leadership, coaching, and employee development skills.
- Effective communication, problem-solving, and decision-making abilities.
- Ability to build cross-functional partnerships and drive operational results.
Qualifications & ExperienceRequired:- Bachelor's degree with 8+ years of industry experience, or Master's degree with 6+ years of industry experience. Equivalent education and experience may be considered.
- Experience leading upstream biologics manufacturing operations in a GMP environment.
- Experience with mammalian cell culture and/or microbial fermentation manufacturing processes.
- Prior experience managing teams in a regulated manufacturing environment.
FormalitiesLocation: Bothell, WA
Schedule: Full-time
Compensation: $108,080 - $148,610
We offer a comprehensive Total Rewards package that may include annual bonus opportunities, paid time off, medical, dental and vision coverage, parental leave, education assistance, employee referral and recognition programs, and additional wellbeing benefits. Eligibility and benefits may vary based on role, location, and employment status.
