QC Analytical Science Technology Sr. Specialist

  • Anywhere

Company :
Adaptimmune Ltd

Location :
Philadelphia, Pennsylvania

Expiry Date :
Mon, 07 Dec 2020 23:59:59 GMT

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Description :
The QCAST Senior Specialist will be the cell Subject Matter Expert (SME) and be responsible for conducting and coordinating technology / method transfer of new and existing cell-based methods from internal and external laboratories. They will lead characterization and cell line maintenance efforts to support QC functions. They will also support method qualifications and validations of cell-based assays. The QCAST Senior Specialist will also take part in the stability testing of Adaptimmune products. When the need arises, this role will also take part in in-process and finished product testing associated with the Adaptimmune clinical trial material. Key Responsibilities Method / Technology Transfer of new methods into the Adaptimmune QC Lab Characterization and Maintenance of Cell lines to support QC functions Maintenance and writing of Quality Control Protocols, SOP’s and Test Methods In-process, finished product and stability testing of clinical trial material Assist in the maintenance and testing of Adaptimmune Stability samples Work collaboratively to develop cell-based assay procedures Qualifications & Experience Required Five to Ten years working in a GMP quality control laboratory Proficient knowledge of GMP regulations including USP and EP testing requirements Experience conducting technology transfers of new methods Experience conducting qualifications and/or validations of analytical methods Extensive experience in cell and tissue culture methods Ability to prepare data trending reports, and to author, review and maintain test methods, qualification protocols, SOPs and reports Conduct laboratory investigations and of prepare deviations and CAPAs as needed Ability to identify and implement continuous improvement projects for lab process efficiencies Ability and desire to effectively work in an interdisciplinary team environment and to effectively interact at multiple levels within the company to support internal manufacturing capabilities Desirable Master’s degree in molecular biology, biomedical sciences or related specialties Ability to work on assigned projects independently with limited supervision. Direct experience validating flow cytometry assays for a GMP laboratory Skills & Compentencies Required Five to ten years experience working in a GMP quality control laboratory Knowledge of GMP regulations including USP and EP testing Method / Technology transfer experience Technical writing skills for drafting equipment and laboratory standard operating procedures Desirable Knowledge of flow cytometry testing Experience performing cell-based assays Experience in coordinating testing activity and data management from contract laboratories At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.