Senior Scientist, Manufacturing Sciences Technology
Expiry Date :
Mon, 21 Dec 2020 23:59:59 GMT
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SUMMARY The MS & T Senior Scientist will be responsible for designing, leading and executing studies to support product and process optimization and automation, investigation on deviation and root cause analysis; technology transfer activities, BLA supporting process and product characterization studies, and any activities required by the MS & T organization. RESPONSIBILITIES Coordinates technology transfer activities as the MS & T lead to support process development and manufacturing operations. Leads investigations to support regulatory filings including but not limited to: deviation investigations during the manufacturing process, root cause analyses relevant to patient products and Adaptimmune cell therapy processes. Provides technical leadership and support for technology transfer, in-process methods optimization, and technology evaluation for MSAT activities. Handles automation, improvement validation, verification of process and in-process analytic equipment. Design, executes and leads BLA process and product characterization studies in support of commercialization. Initiates changes controls, performs data analysis, oversees pre and post implementation activities. Active supervision/mentorship of other junior scientists, and project work stream leadership/management in a matrixed manner in close conjunction with their line managers. Contribute to routine lab maintenance Requirements Four to ten years working in the academic laboratory and/or pharmaceutical industry, preferably a Biotechnology Company, with emphasis on immunological systems, cell therapy, gene therapy, and large scale process development and improvement. MS/PhD in biological sciences, bioengineering or a related field. Extensive knowledge of cGMP regulations including USP and EP testing requirements Experience in authoring and/or reviewing documents for regulatory (FDA, EMA) review Proficiency evaluating data, preparing reports, authoring and reviewing documents, and communicating results to internal and external stakeholders. Conduct laboratory investigations and prepare and communicate deviations and CAPAs as needed 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 Large scale process validation, and knowledge in authoring manufacturing process description and process map using VISIO is a plus. Five to ten years of experience working in a cGMP environment, or pharma/ biotech manufacturing environment in a development, MSAT Lab and/or immunology laboratory. Ability to author and revise Master Batch records Technical writing skills for drafting equipment and laboratory standard operating procedures Process change requirement through the change control system. Large scale tissue culture skills using human primary cells covering static bags and bioreactor. Knowledge of technology transfer including both in-process methods and process transfer experience as both the receiving and sending units. Knowledge of multi-color flow cytometry, cell counting devices, closed system cell washer devices, automated cryopreservation devices. Cryopreservation of human primary T-cells. 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.