Manufacturing Operations Supervisor

4 weeks ago


Philadelphia, Pennsylvania, United States Planet Pharma Full time
Job Summary

We are seeking a highly skilled Manufacturing Operations Supervisor to oversee the manufacturing specialist group at Planet Pharma. This role will execute manufacturing change management, including investigations, document authoring, and deviation management.

Key Responsibilities
  • Oversee and manage day-to-day activities of the Manufacturing Specialist Group.
  • Lead deviation and investigations related to manufacturing operations.
  • Review deviations, non-conformances, and CAPAs as required.
  • Partner with Quality and other cross-functional groups to address issues effectively and compliantly.
  • Manage external contractors who support deviation investigations and closure for manufacturing operations.
  • Coordinate 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.
  • Develop and provide monthly operations metrics and indicators focused on specialist team performance and across manufacturing value streams.
  • Identify and manage projects for continuous improvement opportunities in manufacturing operations in collaboration with the Operational Excellence group and other manufacturing management members.
  • Maintain team capability and readiness via training, performance reviews, and hiring new manufacturing specialist when necessary.
Requirements
  • 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 Qualifications
  • Experience with cell therapy products is a plus.
  • PMP certification is preferred.
  • Fluent in Microsoft Project or comparable software is preferred.
Work Environment
  • This position will work in both an office and a manufacturing lab setting.
  • When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
  • Able to work in cleanroom with biohazards, human blood components, and chemicals.
  • Potential exposure to noise and equipment hazards and strong odors.


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