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Manufacturing Operations Supervisor
2 months ago
We are seeking a highly skilled Manufacturing Operations Supervisor to join our team at Iovance Biotherapeutics Inc. This role will oversee the manufacturing specialist group within our Iovance Cell Therapy Center (iCTC) and execute manufacturing change management, including investigations, document authoring, and deviation management.
Key Responsibilities- Lead and manage day-to-day activities of the Manufacturing Specialist Group.
- Oversee 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.
- 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.
- Experience with cell therapy products is a plus.
- PMP certification is preferred.
- Fluent in Microsoft Project or comparable software is preferred.
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.
Equal Employment OpportunityIovance Biotherapeutics Inc is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.