Overview
The Supervisor, Manufacturing Specialist oversees the manufacturing specialist group. This role will execute manufacturing change management at the facility, including manufacturing investigations, document authoring / editing and deviation management. The Supervisor will also oversee special projects related to continuous improvement or new product introduction in support of the manufacturing group.
Essential Functions and Responsibilities
- Oversees and manage day to day activities of the Manufacturing Specialist Group.
- Responsible to lead deviation and investigations related to manufacturing operations.
- Review deviations, non-conformances, and CAPAs as required.
- Partners with Quality and other cross-functional groups to address issues effectively and compliantly.
- Manages external contractors who support deviation investigations and closure for manufacturing operations.
- Coordinates with team members responsible for procedure and batch record changes to support remediation, continuous improvement, or new product introduction across clinical and commercial value streams.
- Develops and provides monthly operations metrics and indicators focused on specialist team performance and across manufacturing value streams.
- Identifies and manages projects for continuous improvement opportunities in manufacturing operations in collaboration with the Operational Excellence group and other manufacturing management members.
- Maintains team capability and readiness via training, performance reviews, and hiring new manufacturing specialist when necessary.
Required Education, Skills, and Knowledge
- Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
- A minimum of 3 - 5 years of relevant operations experience for clinical and commercial production in the life sciences industry.
- A minimum of 1 year in a supervisory role or corresponding experience in people management.
- Solid knowledge of FDA regulations and GMP systems.
- Solid knowledge of human error reduction strategies, right-first time execution, and just culture.
- Demonstrated project management skills;
- Excellent oral and written communication skills. Strong technical writing ability required.
- Ability to motivate and mentor peers and staff as well as foster a culture of continuous improvement and operational excellence.
- Self-motivated and willing to accept temporary responsibilities outside of initial job description.
- Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
Preferred Education, Skills, and Knowledge
- Experience with cell therapy products is a plus.
- PMP certification is preferred.
- Fluent in Microsoft Project or comparable software is preferred.