Manufacturing Supervisor

• Provides direct guidance, supervision, and assigns tasks to manufacturing personnel, and is present on the floor during all critical process steps.

• Coach, teach, train, and develop employees through 1:1 meeting, performance reviews, 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. Strong business acumen to manage diverse teams.

• Assures all documentation is complete and accurate at the end of every shift.

• Reviews and approves Batch Records, Change Controls, Deviations and other manufacturing documentation required for cGMP production operations.

• Perform cGMP manufacturing tasks in an aseptic manner in an aseptic environment.

• Perform routine transactions with the ERP system including, but not limited to material requisitions, production tracking, updating work orders and production BOMs, etc.

• Responsible for overall cGMP compliance of the department and may represent manufacturing on project teams or during external audits.

• Must have experience in writing technical documents and protocols.

• Able to clearly communicate problems and observations with management from other departments.

• Deliver to Plan: Lead and direct the safety, quality, and daily production operations for suite. Oversee all tasks on the floor as they are carried out and aid with 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

• Adapts departmental plans and priorities to address resource and operational challenges

• Outstanding communication skills (verbal and written) to collaborate with Senior Management in a dynamic environment

• Ensure that the manufacturing facility is in a continuous state of readiness for production and GMP audits

• Administrative tasks - 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

Minimum Qualifications:

Education/Training

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

Experience

Minimum 3 years of manufacturing experience (7+ years' experience without AS/BS); GMP setting preferred, previous people leadership experience required.

Skills/Abilities

Computer software skills, organization, record keeping and planning skills, budget preparation, training skills, multiple projects, time management, facilitation skills

Assure pragmatic problem solving is carried out with a strong sense of purpose and urgency and notify/make recommendations to Management regarding serious compliance or quality issues.

Other

Proven logic and decision-making abilities, critical thinking skills. Aseptic practices and clean room operations

• Statistical and auditing techniques

• Environmental control procedures/equipment

• Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Gene/Viral therapy products focusing on Downstream Operations

• Strong knowledge of current industry trends and can use the latest technologies.