Supervisor, Aseptic Manufacturing
Iovance Biotherapeutics, Inc.
5 hours ago
On-site
Philadelphia, PA
Operations
Supervisor, Aseptic Manufacturing
Responsibilities:
- Supervise and develop direct reports; mentor/coach to foster continuous improvement and operational excellence.
- Schedule and coordinate day-to-day activities; ensure conformance to daily schedule.
- Act as a subject matter expert in aseptic processing; oversee manufacturing to ensure cGMP compliance and proper aseptic techniques.
- Review batch documentation and logbooks for completeness and accuracy.
- Author and revise SOPs, Batch Records, Deviations, CAPAs, and other required documentation.
- Establish objectives, conduct performance reviews, monitor goals, and provide timely feedback to management.
- Drive continuous improvement to enhance efficiency and effectiveness.
- Ensure quality standards compliance; adhere to cGMP and safety regulations.
- Work in cleanroom with biohazards, human blood components, and chemicals.
- Travel: ~10%.
Required/Preferred Qualifications & Skills:
- BS in biology, biochemistry, bioengineering (or related field) or equivalent experience.
- 5+ years in biopharmaceutical GMP manufacturing (cell culture and downstream processing). 2+ years in a leadership/supervisory role desired.
- Demonstrated aseptic processing expertise in cleanroom environments.
- Strong knowledge of regulatory requirements for cGMP manufacturing and quality systems.
- Strong communication and technical writing; experience contributing to training and documentation.
- Experience with end-to-end learning/training processes (needs assessment, design/delivery, evaluation).
- Familiarity with 21 CFR Part 11 and GxP/FDA regulations.
- Ability to work under limited supervision, handle complex problems, and manage ambiguity.
Physical/Other:
- Cleanroom PPE and half-face respirator required; lift/carry up to 45 lbs; stand/walk most of the day.
Responsibilities:
- Supervise and develop direct reports; mentor/coach to foster continuous improvement and operational excellence.
- Schedule and coordinate day-to-day activities; ensure conformance to daily schedule.
- Act as a subject matter expert in aseptic processing; oversee manufacturing to ensure cGMP compliance and proper aseptic techniques.
- Review batch documentation and logbooks for completeness and accuracy.
- Author and revise SOPs, Batch Records, Deviations, CAPAs, and other required documentation.
- Establish objectives, conduct performance reviews, monitor goals, and provide timely feedback to management.
- Drive continuous improvement to enhance efficiency and effectiveness.
- Ensure quality standards compliance; adhere to cGMP and safety regulations.
- Work in cleanroom with biohazards, human blood components, and chemicals.
- Travel: ~10%.
Required/Preferred Qualifications & Skills:
- BS in biology, biochemistry, bioengineering (or related field) or equivalent experience.
- 5+ years in biopharmaceutical GMP manufacturing (cell culture and downstream processing). 2+ years in a leadership/supervisory role desired.
- Demonstrated aseptic processing expertise in cleanroom environments.
- Strong knowledge of regulatory requirements for cGMP manufacturing and quality systems.
- Strong communication and technical writing; experience contributing to training and documentation.
- Experience with end-to-end learning/training processes (needs assessment, design/delivery, evaluation).
- Familiarity with 21 CFR Part 11 and GxP/FDA regulations.
- Ability to work under limited supervision, handle complex problems, and manage ambiguity.
Physical/Other:
- Cleanroom PPE and half-face respirator required; lift/carry up to 45 lbs; stand/walk most of the day.