Senior Bioprocessing Associate
2 weeks ago
Senior Bioprocessing Associate - Cell and Gene Therapy - Contract - Philadelphia, PA
Proclinical is seeking a dedicated individual for the role of Senior Bioprocessing Associate which has a focus on Cell & 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 accordance with current Good Manufacturing Practices (cGMPs). Your expertise in GMP Mammalian Cell Culturing is essential for this position.
Skills & Requirements:
- Proficiency in GMP Mammalian Cell Culturing.
- Strong understanding of aseptic techniques and equipment maintenance.
- Basic technical knowledge in the pharmaceutical and biotechnology industry.
- Experience with facility start-ups and technical transfer activities.
- Proficiency in using support systems like LIMS.
- Ability to collect, analyze, and communicate scientific and process data.
- Familiarity with compliance and regulatory requirements, including cGMPs.
- Basic computer skills, including Microsoft applications.
- Strong problem-solving skills and ability to suggest and implement continuous improvement ideas.
The Senior Bioprocessing Associate's responsibilities will be:
- 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, creating and revising material documents.
- Use 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.
- Assist with regulatory inspections and client audits, coordinating with internal groups to resolve issues.
- Perform tasks independently and under supervision, delegating work assignments as necessary.
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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