Cell Therapy Manufacturing Specialist II

Cell Therapy Manufacturing Specialist II - Contract - Philadelphia, PA

Proclinical is seeking a dedicated GMP Cell Therapy Manufacturing Specialist to join the team.

Primary Responsibilities:

This role will focus on executing cell therapy manufacturing processes while adhering to quality standards and Good Manufacturing Practices (GMP). Your expertise in aseptic techniques and process documentation will be crucial for maintaining compliance and ensuring product quality.

Skills & Requirements:

• Bachelor's degree in a relevant field.
• Proven history of aseptic processing in cleanroom environments.
• Experience in GMP manufacturing operations, including aseptic techniques and equipment use.
• Ability to work independently and collaboratively in a team.
• Strong quality mindset and familiarity with FDA regulations and GxP practices.
• Proactive and results-oriented approach in a complex manufacturing environment.

The Cell Therapy Manufacturing Specialist II's responsibilities will be:

• Execute GMP cell therapy manufacturing processes with proficiency.
• Perform cell counts, operate cell wash and concentration machines, and manage bioreactors.
• Conduct aseptic tube welding, sealing, and liquid transfers.
• Perform mathematical calculations and manage in-process materials.
• Collect and submit samples, escalating issues as needed.
• Train and maintain Aseptic Process Qualifications (APQs).
• Manage final product formulation, media preparation, and tumor processing.
• Perform environmental monitoring and document duties using electronic systems.
• Operate biosafety cabinets, liquid repeater pumps, and other equipment.
• Handle material transfers, tumor receipt, and product cryopreservation.
• Review documents in real-time and maintain gowning qualifications.
• Attend meetings to escalate issues and support team operations.
• Comply with safety protocols and regulatory requirements.
• Support operational functions, including materials management and equipment maintenance.
• Facilitate training sessions and support departmental projects.

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@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.

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