Senior Supervisor, Downstream Manufacturing
The Senior Supervisor, Downstream Manufacturing, will supervise production processes and manufacturing personnel. This position will lead the transition of new processes from PD to manufacturing, will review and approve Batch Records, Change Controls, Deviations and other manufacturing documentation required for cGMP production operations and coordinate the production schedule while maintaining raw material inventory to support. The senior supervisor will perform such cGMP manufacturing tasks as operation of medium-scale cell culture bioreactors, large scale chromatography and aseptic filling. This role will ultimately be responsible for overall cGMP compliance of the department and may represent manufacturing on project teams or during external audits.
Lead and direct the safety, quality, and daily production operations for suite. Oversee all tasks on the floor as they are carried out and provide assistance and troubleshooting where required. Coordinate with other departments to ensure on time delivery of the production schedule.
Monitor and coach staff to ensure full compliance with GMP and Quality system requirements. Responsible for overall inspection readiness and compliance with quality requirements. Lead and oversee the on-time completion of document review (batch record, logbook, SOPs) for completeness, clarity, accuracy to support on-time release of batches with minimal errors
Coach, teach, train and develop employees through 1:1 meetings, performance review and management, and career planning activities. Support recruiting, staffing, hiring, onboarding performance management, promotion and discipline of operators as appropriate. Maintain individual training plan and ensure team remains up to date with training readiness.
Leading shift exchange, assigning duties, attending meetings, sending/receiving emails, participating in continuous improvement projects. Demonstrate strong technical writing abilities (deviation initiations, SOP creation, etc.).
Perform other duties as assigned.
Expected work schedule: Any combination to include but not limited to M-F, Alternating Days, 8, 10, and 12 hours shifts. Ability to work nights, weekends and holidays.
AS/BS in Biotechnology, Biology, Chemistry, or equivalent. Preferred area of study: Science related discipline. High School Diploma or Equivalent may be considered with relevant experience
7+ years’ experience in manufacturing (12+ years’ experience without AS/BS); GMP setting preferred, previous supervisory experience preferred.
Proven logic and decision-making abilities, critical thinking skills. Aseptic practices and clean room operations
Must have experience in writing technical documents and protocols and possess the ability to clearly communicate problems and observations with management from other departments