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.
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