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Senior Scientist - Process Development, Upstream

Company: Wuxi Apptec
Location: Philadelphia
Posted on: July 15, 2019

Job Description:

Job Locations US-Philadelphia Job ID 2019-5380 Overview The Sr. Scientist position will be responsible for supporting upstream cell culture process platforms as well as developing and assisting client based processes with a focus on Cell and Gene therapy programs. The incumbent will actively participate in the development of suspension and adherent cell culture processes as well as vector production and transduction methods. In addition, the candidate will contribute in the continuous improvement of WuXi Advance Therapies Unit infrastructure and capabilities for upstream process by implementing new technologies. The candidate will work with his immediate supervisor to establish and execute work plans associated with client base projects and development of new platforms for Cell and Gene therapy. Responsibilities * Responsible for successful scale up and technology transfer of Cell and Gene Therapy products. * Supports oversight of training for PDT and MFG personnel * Serves as a technical lead for process scale up projects, responsible for engineering solutions during scale up of client processes. * Applies understanding of regulatory expectations to GMP Manufacturing strategies. Contributes to process risk assessments. Justifies manufacturing strategies and designs. * Responsible for trouble shooting, deviation investigation and product impact assessment for projects employing developed technology/processes. Serves as an internal subject matter expert (SME). * Responsible for activities required for successful operation of assigned project area including: Writing detailed experimental protocols, coordinating activities in the laboratory, developing Bill of Materials (BOM), executing and documenting experimental studies according to local Standard Operating Procedures (SOPs) or established practices, reviewing and reporting data, and contributing to technical reports. * Interacts internally with Manufacturing, Engineering, Facilities, Validation, Quality Assurance, Quality Control, Project Management, and Materials Management groups. Interacts externally with clients, material/equipment vendors and commercial partners. * Reviews laboratory notebooks and logbooks. * Contributes to operations of the process development lab, including training of new employees. * Understands and applies principles of biosafety to maintain a safe workplace for self and others. * Reviews tech transfer report from small scale process development * Reviews process transfer protocol with small scale process development and provides input for the studies that need to be performed in order to ensure successful scale up. Qualifications * Bachelors, Masters' or PhD degree in Biological Sciences or Engineering field * 6 - 10 years of relevant experience with a Bachelors' degree or * 4 - 8 years of relevant experience with a Masters' degree or * 2 - 4 years of relevant experience with a PhD. or equivalent * Experience in upstream, downstream or formulation process development is required. Familiarity with cell and gene therapy products is preferred, but experience with protein purification/formulation will also be considered. * Experience with procedures for the isolation, transduction/activation, expansion and cryopreservation of gene modified patient derived cells. * Familiarity with handling of apheresis materials and / or whole blood and related cell processing equipment is preferred. * Possesses knowledge of viral vector production at small and/or large scale. * Experience with purification of viral vectors is strongly preferred, including chromatography, centrifugation, filtration and TFF. * Experience with wave or stirred tank bioreactors is a plus. * Ability to perform complex mathematic and statistical calculations and data analysis, and to work with Excel and other scientific data analysis tools to collect and analyze data. * Works in laboratory and production environments with potential exposure to occupational hazards including chemical cleaners, biohazardous materials, noise, mechanical and heat/cold energy. * Must be able to wear all required Personal Protective Equipment (PPE). Our Values: Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right. Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team. WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. Options

Keywords: Wuxi Apptec, Philadelphia , Senior Scientist - Process Development, Upstream, Other , Philadelphia, Pennsylvania

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