Upstream Manufacturing Supervisor - Permanent - Philadelphia, Pennsylvania PA
Proclinical is seeking a dedicated and organised individual for the role of Upstream Manufacturing Supervisor. This permanent position is based in Philadelphia, Pennsylvania.
Primary Responsibilities :
The successful candidate will be responsible for overseeing and leading the production of Master and Working Cell Banks, as well as supporting the production of Cell & Gene Therapy products in accordance with current Good Manufacturing Practices (cGMPs).
Skills & Requirements :
- HS Diploma or equivalent required, BS / BA in Science related field preferred.
- Minimum of 5 years of relevant technical experience, with at least 2 years in a Lead / Leadership / Supervisory Role.
- Strong understanding of cGMP regulations and manufacturing processes.
- Excellent leadership, coaching, and mentoring skills.
- Strong problem-solving and data interpretation skills.
- Excellent communication skills, with the ability to interact effectively with internal and external stakeholders.
The Upstream Manufacturing Supervisor's responsibilities will be :
- Give training and mentorship as well as oversee basic aseptic operational techniques, solution preparation, and facility start-up.
- Perform complex troubleshooting and oversee the sourcing and purchasing of standard and complex equipment.
- Review and approve solution and material preparation results, protocols, and other technical transfer documents.
- Execute in-house and offsite validation activities and perform material procurement activities.
- Act as a lead or member of a systems improvement team, with a focus on understanding and improving manufacturing processes and methods.
- Interpret data, identify process and method gaps, and implement improvements across assigned programs.
- Ensure compliance with cGMP regulations and address any compliance and regulatory issues.
- Oversee staff training on Batch record, SOPs, equipment, and all unit operations.
- Author, review, and approve technical documents such as non-conforming events and deviations.
- Lead and implement continuous improvement initiatives.
- Manage staff performance, job expectations, and work assignments to ensure adequate staffing across assigned programs.
5 days ago