Manager, Manufacturing - Bothell WA

Military Spouse Corporate Career Network•Bothell, WA

2d•Onsite

About The Position

The Manufacturing Manager I leads the execution of manufacturing processes for cell therapies in accordance with established electronic work instructions, production records, and current Good Manufacturing Practices (cGMP). The role leads a team focused on manufacturing execution, technical process assessment, and a culture of safety, compliance, and innovation. It provides technical guidance for troubleshooting, investigations, process and equipment data analysis, and process improvements, while promoting idea generation, teamwork, and reliable, repeatable operations. The manager plans and oversees daily operations and resources, maintains compliant and inspection-ready areas, and drives right-first-time performance and continuous improvement. The role oversees documentation and change controls, deviations, investigations, corrective and preventive actions, training compliance, and coordination with cross-functional partners. It also provides hands-on support in the cell therapy manufacturing facility, coaches manufacturing personnel, and hires, mentors, develops, and evaluates 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.
Two years of leadership experience, such as lead or equivalent, including performance-management responsibilities, is highly desirable.
Ability to work in a cleanroom and perform aseptic processing in ISO 5 biosafety cabinets as needed, using gowning and personal protective equipment.
Ability to work in a BSL-2 / ML-1 environment handling human blood components.
Ability to work in areas with strong magnets and exposure to vapor-phase liquid nitrogen.
Ability to work the assigned shift, which may include days, evenings, nights, weekends, and/or holidays.
Ability to stand and walk for extended periods.
Ability to lift and/or carry up to 30 pounds several times a day and push and/or pull up to 50 pounds several times a day while handling production equipment or materials.

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.
Experience with cell washing processes, cell separation techniques, and cryopreservation processes and equipment.

Responsibilities

Manage the creation, implementation, and compliance of Source Governing Documents, including standard operating procedures, work instructions, batch records, and forms.
Oversee operations within validated manufacturing systems.
Plan resources, assign work, oversee daily operations in assigned areas, and control costs.
Maintain operating and storage areas so they are compliant, efficient, safe, and inspection-ready.
Drive right-first-time initiatives, hold the team accountable for compliance performance, and develop solutions to compliance issues.
Prepare, align on, and implement change controls; initiate notices of events, deviations, and investigations; and drive assigned actions to closure.
Complete and present MRB slides at MRB meetings as needed.
Evaluate team performance and drive continuous improvement in cost, quality, safety, culture, and delivery.
Identify strategic and operational issues that could cause deviations or threaten compliance.
Lead the 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.
Foster teamwork, open communication, urgency, psychological safety, workplace safety, and patient safety through compliance with company procedures and cGMP requirements.
Coordinate and communicate operational project information and status with Planning, Manufacturing, Quality Assurance / Operations, Global Supply, and other functions according to schedules and implementation timelines.
Maintain a presence in the cell therapy facility to participate in walk-throughs, troubleshoot processes, participate in event triage, and coach manufacturing personnel.
Oversee operators performing manufacturing and support operations safely and in accordance with Source Governing Documents, completing required contemporaneous documentation, and maintaining training compliance.
Support manufacturing-area and equipment setup, facility and equipment commissioning, and qualification and validation activities.
Write technically sound manufacturing operating procedures that support efficient operations and comply with cGMP requirements.
Hire, mentor, and develop manufacturing personnel; conduct documented performance reviews; identify career-growth opportunities; and promptly address performance issues through documented coaching or feedback.