Bioprocessing Associate III - Cell & Gene Therapy

Bioprocessing Associate III - Cell & Gene Therapy - Contract - Philadelphia PA

Proclinical is seeking a dedicated individual for the role of Bioprocessing Associate III with a focus on Cell and Gene Therapy.

Primary Responsibilities:

The successful candidate will be responsible for the manufacture of Master and Working Cell Banks and supporting the production of Cell & Gene Therapy products. This includes final product fills in compliance with current Good Manufacturing Practices (cGMPs). Experience in a GMP environment and mammalian cell culturing is essential.

Skills & Requirements:

• Experience in a GMP environment and mammalian cell culturing.
• Basic technical knowledge in the pharmaceutical and biotechnology industry.
• Fundamental engineering and mechanical knowledge applicable to manufacturing.
• Proficiency in using support systems like LIMS.
• Strong understanding of cGMP compliance and regulatory requirements.
• Basic computer skills, including Microsoft applications.
• Ability to work independently and under direct supervision on basic tasks and processes.

The Bioprocessing Associate's responsibilities will be:

• High School diploma and over 6 years of relevant experience
• Associates'/Bachelor's (science preferred) degree with over 3 years of relevant or equivalent experience.
• Proven working history within a GMP environment is a necessity.
• Experience in performing mammalian cell culturing.
• Train others in aseptic techniques.
• Operate, maintain, and troubleshoot equipment, ensuring corrective maintenance as needed.
• Assist with sourcing and purchasing standard equipment.
• Prepare solutions and materials, and manage material procurement activities.
• Participate in facility start-ups and technical transfer activities, providing feedback and ensuring GMP compliance.
• Execute and review validation activities and documentation.
• Schedule, receive, and organize materials, resolving any discrepancies.
• Collect, record, analyze, and interpret scientific and process data, communicating findings to stakeholders.
• Follow and improve Standard Operating Procedures (SOPs) and Batch Records (BRs), training others as needed.
• Support regulatory inspections and client audits as a subject matter expert.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 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.

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