Bioprocessing Associate III - Cell & Gene Therapy
- Contract
- Bioprocessing
- United States
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.
INDSCIC
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