Manager, Manufacturing - Bothell WA
About The Position
The Manufacturing Manager I leads and drives manufacturing processes for cell therapies in accordance with electronic work instructions, production records, and current Good Manufacturing Practices (cGMP). The role leads a team focused on manufacturing execution, technical process assessment, and building a culture of safety, compliance, and innovation. It provides technical guidance for troubleshooting, investigations, process and equipment data analysis, and process improvements, while fostering idea generation, cross-functional collaboration, and reliable, repeatable execution. The manager oversees daily operations in assigned areas, maintains compliant and inspection-ready facilities, and coordinates manufacturing activities with planning, quality, global supply, and other functions. The role is based in a cell therapy manufacturing facility and includes direct engagement with manufacturing personnel, including process troubleshooting, event triage, and coaching. The manager also hires, mentors, trains, evaluates, and develops team members.
Requirements
- Bachelor’s degree in a relevant science or engineering discipline, or equivalent work experience.
- At least 5 years of experience in cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience.
- At least 2 years of leadership experience, such as lead or equivalent, including performance management responsibilities, is highly desirable.
- Ability to stand and walk for extended periods.
- Ability to work in a cleanroom and perform aseptic processing in ISO 5 biosafety cabinets as needed, wearing required gowning and personal protective equipment.
- Ability to carry and/or lift up to 30 pounds several times a day while handling production equipment or materials.
- Ability to push and/or pull up to 50 pounds several times a day while handling production equipment or materials.
- Ability to work in areas that may have strong magnets.
- Ability to work in a BSL-2/ML-1 environment handling human blood components.
- Ability to work in areas with exposure to vapor-phase liquid nitrogen.
- Ability to work the assigned shift, which may include days, evenings, nights, weekends, and/or holidays.
Nice To Haves
- Experience in cell therapy manufacturing.
- Experience with aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human-derived materials in BSL-2/ML-1 containment areas.
- Experience with cell expansion using incubators and single-use bioreactors, cell washing processes, cell separation techniques, and cryopreservation processes and equipment.
Responsibilities
- Manage the creation, implementation, and compliance of source governing documents, including SOPs, work instructions, batch records, and forms, for cell therapy operations.
- Oversee operations within validated manufacturing systems.
- Plan resources and oversee daily operational activities in assigned areas while controlling costs.
- Maintain operating and storage areas so they remain compliant, efficient, effective, safe, and inspection-ready.
- Drive right-first-time initiatives, hold the team accountable for compliance performance, and develop solutions to compliance issues.
- Prepare, gain alignment on, and implement change controls.
- Complete MRB slides and present at MRB meetings as needed.
- Initiate change controls, notices of events, deviations, and investigations, and drive assigned actions to closure.
- Evaluate team performance and drive continuous improvement in cost, quality, safety, culture, and delivery.
- Identify strategic and operational issues to prevent deviations; lead development of corrective and preventive actions, deviation responses, and investigations.
- Verify that manufacturing associates and team leads are trained on their curricula before performing GxP tasks.
- Promote teamwork, open communication, urgency, psychological safety, workplace safety, patient safety, and compliance with company procedures and cGMP requirements.
- Coordinate and communicate operations project information and activity status to planning, manufacturing, quality assurance/operations, global supply, and other functions in accordance with schedules and implementation timelines.
- Be present in the cell therapy manufacturing facility for walkthroughs, process troubleshooting, event triage, and timely coaching of manufacturing personnel.
- Oversee operators performing unit and support operations safely and in compliance with source governing documents.
- Ensure operators complete required contemporaneous documentation and maintain training compliance.
- Oversee assistance with manufacturing area and equipment/fixture setup, facility and equipment commissioning, and qualification and validation activities.
- Write technically sound manufacturing operating procedures that promote effective and efficient operations and comply with cGMP requirements.
- Hire, mentor, and develop employees; conduct documented performance reviews, identify career-growth opportunities, and promptly address performance issues through coaching or feedback.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
