Our clinical-stage vaccine client based in Boston, MA is looking to add a Team Lead/Sr. Scientist, Purification to their Manufacturing Sciences and Technology team! This role will lead the vaccine tech transfer and process development through the application of processes, procedures, and technologies in the development of best-in-class vaccines, and scale up manufacturing. Responsibilities include but not limited to:
- Providing expertise for the scale up, tech transfer, and validation, of purification unit operations to internal and external partners in support of clinical/commercial manufacturing of vaccine products.
- Ensuring full alignment with Downstream tech transfer deliverables.
- Provide leadership in the qualification, validation, and technical transfer of unit operations pertaining to purification of virus-like particles (VLPs).
- Serving as a subject matter expert for purification unit operations to both internal and external stakeholders.
- Working with internal resources to identify potential improvements for existing downstream processes.
- Overseeing the planning and execution of small-scale experiments to support internal reagent manufacturing as well as process characterization and scale-up.
- Communicating technical information to Senior Management and external partners.
- Writing and reviewing technical documents and regulatory submissions.
- Supporting ongoing technical transfer and manufacturing at CDMOs through acting as the person in the plant and providing technical oversight to assist with troubleshooting.
- Providing technical input to the Quality organization with regards to GMP deviations and CAPAs as needed.
- Supporting development and commercial operations groups in the preparation of relevant regulatory filings.
- PhD and a minimum of 3 years’ experience or MS and a minimum of 8 years’ experience in protein purification of antibodies, VLPs or other similar recombinant proteins.
- Demonstrated technical expertise in purification of recombinant proteins utilizing column chromatography and tangential flow filtration.
- Well-developed knowledge of cGMP practices as applicable to technology transfer, manufacturing, formulation, and analytical development.
- Proficiency in statistical software (JMP, R, etc.) for data analysis and tracking and trending.
- Established external network of service providers, technical experts, suppliers, and technology providers.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Up to 20-30%.