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.