Senior Bioprocessing Associate - Cell and Gene Therapy

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