We are currently seeking a QC Microbiology Manager to join the Forge Biologics team. In this newly created role, the QC Microbiology Manager is responsible for overseeing the daily operations of the Microbiology Department including environmental monitoring testing programs and in-process and product release testing, to ensure compliance with cGMP standards.
The QC Microbiology Manager will provide technical support regarding method verification, environmental monitoring, utilities and new technology. The QC Microbiology Manager will have oversight of the Micro, Physical Monitoring, and Environmental Monitoring teams at Forge, which include scientists, analysts, and technicians. These teams serve a wide array of internal and external customers and require close coordination with Quality and Regulatory groups as well.
- Managing the overall operations in the QC microbiology lab, assuring regulatory compliance including State, Federal, and Corporate compliance.
- Responsible for microbiological testing of raw materials, in-process materials, finished product, and various environment/utility tests.
- Manage EM program (EM sampling and Testing) and EM analysts.
- Leads corrective action/preventive action (CAPA) for microbiological/EM quality events, and reviews corrective actions and assesses implementation of action.
- Develop, implement, and monitor laboratory methods and documents (e.g., SOPs, Work Instructions, etc.).
- Assess and implement continuous improvement of laboratory efficiency and the EM program.
- Assess and implement applicable cost improvement plans related to the lab and microbial testing.
- Serve as a technical resource for other business units.
- Represents the QC microbiology function for all external quality and regulatory audits.
- Train all EM and Micro personnel.
- Responsible to maintain high quality levels on all products while achieving high efficiency.
- Responsible for GMP compliance, manufacturing quality, laboratory support, and quality planning.
- Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback.
- Sets goals which align to department plans and manages the execution of goals through coaching and mentoring.
- Maintains a safe and professional work environment.
- Complies with U.S. Food and Drug Administration (FDA) regulations, EU GMP and other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Works directly with Senior Management and Leadership to assure process communications are occurring in a timely manner.
- Coordinate and participate in construction efforts for the phased build out of the facility as well as the continued support of the facility moving forward.
- Bachelor’s Degree in Microbiology, Biology, or equivalent. Minimum 5 years’ experience Pharma, Biotech, or regulated/GMP industry preferred.
- Minimum 1 year of Supervisory experience.
- Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
- Excellent oral and written communication skills
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Ability to work hours necessary to support production and/or product transfer activities.
- Ability to present to and interact with Senior Management and Leadership teams.
- Travel Requirements: 0 - 15%.
Special Knowledge or Skills Preferred:
- Experience in high-level interactions with domestic and international Regulatory agencies.