Biologist

A Biologist job in Rockville, MD is available through Adecco Medical & Science.
Responsibilities:
Work products and documents related to performing manufacturing of novel cellular therapy products, including cellular therapy and chimeric antigen receptor T cells; organize records forms and labels necessary for HCT/P manufacture. - Ad-Hoc Work products and documents related to performing trouble shooting during HCT/P manufacturing and assay performance; document actions required to resolve problem and initiate corrective action; perform required quality control steps as outlined in SOPs; perform data retrieval and entry using multiple IT systems. - Ad-Hoc Work products and documents related to interpreting experimental techniques and procedures; reports on laboratory results, written evaluation of procedures including detected deficiencies/defects, and reports on cellular therapy products and research protocols. - Ad-Hoc Work products and documents related to maintaining up-to-date knowledge of regulatory requirements; attend weekly CPS staff meetings or review minutes of the meeting if unable to attend. - Ad-Hoc submission schedules and SRT member presentations, organizing scientific presentation preparation and virtual recordings. - Ad-Hoc Work details and description:
Perform manufacturing of novel cellular therapy products, including cellular therapy and chimeric antigen receptor T cells 1 Organize records forms and labels necessary for HCTP manufacture 2 Perform trouble shooting during HCTP manufacturing and assay performance; documentations required to resolve problem and initiate corrective action as needed 3 Perform required quality assurance steps as outlined in SOPs Perform data retrieval and entry using multiple IT systems Perform cleaning of biosafety cabinets, equipment and supplies Interpret experimental techniques and procedures; prepare reports on laboratory results Prepare written evaluation of procedures including detected deficiencies defects, and reports on cellular therapy products and research protocols Critically evaluate laboratory data presentations Perform validation studies on equipment, facilities, and processes Perform experiments to validate novel manufacturing techniques Document product manufacturing data in compliance with Good Documentation Practices GDP Inventory and order supplies with NIH approval for clinical manufacturing Maintain up-to-date knowledge of regulatory requirements as defined by current version of CPS Drug Master File, applicable sections of FDA Code of Federal Regulations and current edition of AABB Standards for Cellular Therapy Product Services; regularly review CPS PSI and SOP manuals to stay current with procedural revisions Attend weekly CPS staff meetings or review minutes of the meeting if unable to attend Independently prepare drafts of executive briefing documents/presentations; gather, organize, and summarize selected information; prepare presentation slides to comply with Institute and conference formats. Qualifications:
Education:
Certifications & Licenses
Ph.D. in Medical Technology, Biology, Life Sciences or a related discipline.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records