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.