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.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at (+1) 267 428 7770 or m.
raletz@proclinical.com .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
INDSCIC
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