Scientist contributing to the development of early and late stage clinical manufacturing processes and commercial manufacturing processes for Cell and Gene Therapies. This position will work with a team of scientists and technical specialists responsible for process development, technology transfer and GMP manufacturing to ensure the application of well-designed unit operations for inclusion in routine manufacturing operations supplying clinical and commercial materials. Responsible for supporting development project leads in the development, scale-up/out, and verification of clinical and commercial manufacturing processes. Contributes to operations of development team, and may support tech transfer activities as necessary. Demonstrates strong oral and written communication skills. Contributes to the achievement of company and departmental goals and objectives.
* 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, downstream processing of cell products, production of viral vectors, and downstream processing of viral vectors
* Contributes to activities required for successful operation of assigned project area including:
* Writes detailed experimental protocols, reviews and reports data appropriately, contributes to technical reports
* 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
* Monitors and communicates inventory needs to the departments Materials Management group
* Communicates status of operations, safety and maintenance problems, in a timely manner to Area Management
* Contributes to training of new 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
* Effectively communicates with clients and vendors
* Ability to work in a team environment and independently as required
* Maybe required to work Holidays and weekends
* Other duties as assigned
* May be required to assist in other departments
* Bachelors or Masters' degree in Biological Sciences or Engineering field
* 2-4 years of relevant experience with a Bachelors' degree or 0-2 years of relevant experience with a Masters' degree
* Experience in upstream bioprocess unit operations such as aseptic processing techniques, culture of adherent and/or anchorage dependent cells, molecular assays, and 3D bioreactors are required
* Experience in downstream bioprocess unit operations such as centrifugation, cell washing techniques, filtration systems, tangential flow filtration and chromatography is required
* Experience with authoring technical transfer protocols for cell banking and cell/gene therapy products
* Ability to work with moderate supervision, apply judgement in real-time, and deal with problems of a difficult nature
* 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
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.