Bioprocessing Associate III - Cell & Gene Therapy

Bioprocessing Associate III - Cell & Gene Therapy - Contract - Philadelphia PAProclinical 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 experienceAssociates'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 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

Created: 2024-11-06