Independent scientist contributing to the development of early and late-stage clinical manufacturing processes and commercial Viral Vector manufacturing processes. 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 development, scale-up/out, and verification of clinical and commercial manufacturing processes. Contributes as to tech transfer and manufacturing activities as necessary. Demonstrates strong oral and written communication skills and supports client-facing activities for the Process Development team. Actively contributes to the achievement of company and departmental goals and objectives.
• Responsible for successful Downstream process development and technology transfer of Viral Vector products, including chromatography, TFF, and filtration.
• Applies understanding of the scientific fundamentals of purification unit operations used in viral vector manufacturing to develop and justify development strategies and experimental designs.
• Serves as a technical lead for process development projects, responsible for experimental design of process development studies, applying Quality by Design principles and Design of Experiment methodologies where appropriate.
• Applies understanding of regulatory expectations to process development strategies. Contributes to process risk assessments.
• Responsible for troubleshooting, 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 the 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.
• Communicates the status of operations, safety and maintenance problems promptly to Area Management.
• Monitors and communicates inventory needs to the department's Materials Management group.
• Responsible for training new employees on areas of technical expertise and compliance issues relevant to the lab setting.
• 4-6 years of relevant experience or equivalent with a Bachelors’ degree
• 2-4 years of relevant experience or equivalent with a Masters’ degree
• 0-2 years of relevant experience or equivalent with a Ph.D. degree
• Degree with a focus on Biological or Chemical Engineering, Biological Sciences or another science-related topic
Knowledge / Skills / Abilities:
•Experience with the development of downstream bioprocess unit operations such as tangential flow filtration and chromatography.
• Knowledge of cGMPs is preferred.
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
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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.