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Senior Scientist, Process DevelopmentPosted by: WuXi AppTec Inc.
Posted date: Dec-27-2017
Location: Philadelphia, PA
WuXi AppTec is a leader in manufacturing and development of CAR-T, stem cells, viral vectors (Lentivirus, AAV, etc.), and other autologous and allogeneic therapies. The process development group within WuXi AppTec is looking for an associate scientist in who is passionate about helping advance these novel therapeutics to patients around the world while collaborating with many leading companies in the industry. The work includes development of early and late stage clinical and commercial manufacturing processes and is fast paced and constantly changing. This position will work with a team of scientists and technical specialists responsible for process development and characterization, technology transfer and GMP manufacturing to ensure the application of well-designed and robust unit operations for inclusion in routine manufacturing operations supplying clinical and commercial materials. The candidate will be responsible for development, scale-up/out, and verification of clinical and commercial manufacturing processes. They will contribute to tech transfer and manufacturing activities as necessary. The group is looking for candidates that demonstrate strong oral and written communication skills to be used when supporting development and tech transfer teams. The group is looking for a team player that has a desire to learn while achieving company and department goals
Supports the successful process development and technology transfer of Cell and Gene Therapy products. Areas of focus include culture of adherent and suspension primary cells, cell strains, and immortalized cell lines, production of viral-vectors and downstream processing of cell products and viral vectors.
Independently performs activities required for successful operation of assigned project area including:
Designs experiments and writes detailed experimental protocols, reviews and reports data appropriately.
Authors technical reports.
Leads, executes and documents experimental studies, authors local Standard Operating Procedures (SOPs) and purchasing plans.
Contributes to coordination of activities in the laboratory, maintains laboratories and equipment, reviews and signs logbooks.
Communicates status of operations, safety and maintenance problems, in a timely manner to Area Management.
Trains and mentors employees on areas of technical expertise and compliance issues relevant to the lab setting.
Understands and applies principles of biosafety to maintain a safe workplace for self and others.
Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
Effectively communicates with clients, vendors, and cross functions teams
Bachelor’s with major in Biology, Biochemistry, and Bioengineering or related Science major with 2 - 4 years of industry experience in cell production/biologics research, development or manufacturing. Master’s with major in Biology, Biochemistry, and Bioengineering or related Science major with 0 - 2 years of industry experience. PhD with major in Biology, Biochemistry, Bioengineering or related Science major with 0 years of industry experience.
Experience in upstream bioprocess unit operations such as aseptic processing techniques, culture of adherent and/or anchorage dependent cells, molecular assays, and 3D bioreactors is required.
Ability to perform complex mathematic and data analysis, and to work with Excel and other scientific data analysis tools to collect and analyze data. Experience with statistical analytical software (JMP/Minitab/SPSS) is preferred.
Ability to clearly express and exchange ideas by means of verbal and written communication with clients and vendors.
Ability to work with moderate supervision, apply judgement in real-time, and deal with problems of a difficult nature.
Desire to work in a cross-functional team environment
Experience in downstream bioprocess unit operations such as centrifugation, cell washing techniques, filtration systems, tangential flow filtration and chromatography
Experience with authoring technical transfer protocols for cell banking and cell/gene therapy products.