Bioprocessing Associate II, Cell & Gene Therapy - Contract - Philadelphia PA
天涯社区官网 is seeking a dedicated Bioprocessing Associate II to focus on Cell and Gene Therapy.
Primary Responsibilities:
This role will be responsible for the manufacture of Master and Working Cell Banks, supporting the production of Cell & Gene Therapy products, and ensuring final product fills adhere to current Good Manufacturing Practices (cGMPs).
Skills & Requirements:
- High School diploma alongside 6+ years of relevant experience or an Associate's/Bachelor's degree in a science-related field with 1+ years of relevant experience.
- Basic technical knowledge in the pharmaceutical and biotechnology industry.
- Fundamental engineering and mechanical knowledge applicable to manufacturing.
- Experience with facility start-ups and technical transfer activities.
- Proficiency in using support systems and basic Microsoft applications.
- Strong understanding of cGMP compliance and regulatory requirements.
- Ability to train and mentor others, and work independently on basic tasks and processes.
The Bioprocessing Associate II's responsibilities will be:
- Apply and train others in aseptic techniques, ensuring compliance and correcting practices as needed.
- Operate, maintain, and troubleshoot equipment, identifying needs for corrective maintenance.
- 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, creating and revising material documents.
- Use support systems (e.g., LIMS) proficiently and act as a subject matter expert.
- 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.
- Participate in the development of technical documents and continuous improvement initiatives.
- Support regulatory inspections and client audits, coordinating with internal groups to resolve issues.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com
天涯社区官网 is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
天涯社区官网 Staffing is an equal opportunity employer.
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