Independent scientist contributing to the development of early and late stage clinical manufacturing processes and commercial Cell Therapy 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.
* Responsible for successful process development and technology transfer of Cell Therapy products, including adherent and suspension primary cells, cell strains, and immortalized cell lines.
* Applies understanding of the scientific fundamentals of cell culture and purification unit operations used in cell therapy 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 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.
* Communicates status of operations, safety and maintenance problems in a timely manner to Area Management.
* Monitors and communicates inventory needs to the departments Materials Management group.
* Responsible for training 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.
* Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
* Other duties as assigned
* May be required to assist in other departments
* Bachelor's degree with major in Biological or Chemical Engineering, Biological Sciences or other science-related major
* 6+ years of relevant experience or equivalent
* Possesses thorough knowledge of the science of cell culture, including growth and characterization of primary cells, cell strains, and immortalized cell lines.
* Experience with development of upstream bioprocess unit operations such as 2D and 3D bioreactors, and downstream bioprocess unit operations such as tangential flow filtration and continuous flow centrifugation is preferred.
* Experience with media development is preferred.
* Experience in aseptic processing techniques is required, and knowledge of cGMPs is preferred.
* 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.