Our Vaccine client in Boston, MA is growing and looking to add a Sr. Scientist, Purification to their Manufacturing Sciences and Technology team! Role will be responsible for providing expertise for the scale up, tech transfer, engineering run readiness and validation, of downstream unit operations in support of clinical/commercial manufacturing of vaccine products. Other responsibilities include but not limited to:
- Manage CDMOs for Downstream tech transfer timelines and deliverables.
- Acting as a cross-functional subject matter expert in the organization to promote scientific and operational excellence.
- Lead process design, development and scale up of downstream unit operations including column chromatography, Ultrafiltration, virus clearance and TFF operations
- Generate criticality assessments, Product quality risk assessments and lead FMEAs at the CDMO to support large scale tech transfer cross functionally
- Perform gap assessments and design mitigation plans and studies in collaboration with the CDMOs to de-risk Manufacturing runs
- Drive design, development and execution of studies to support life cycle management and continuous improvement initiatives.
- Supporting ongoing technical transfer and manufacturing at CDMOs through acting as the person in the plant and providing technical oversight to assist with troubleshooting.
- Support Root cause investigations and deviation management in partnership with Quality
- Providing technical input to the Quality organization with regards to CAPAs as needed.
- Trend process data for ongoing batches and communicate to senior leadership
- Assess process data and develop and/or recommend product specification ranges
- Drive process characterization studies to map design space (PARs and NORs) at the CDMOs
- 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.
- Supporting development and commercial operations groups in the preparation of relevant regulatory filings.
Requirements:
- Masters or PhD in Chemical Engineering, Pharmaceutical sciences or equivalent. Ph.D is preferred.
- A minimum of 3 years’ experience (Ph.D) or MS with a minimum of 5 years’ experience in downstream process development, scale up and tech transfer of GMP operations is required.
- Direct experience with recombinant VLPs or vaccines is highly desirable
- Some experience working with CDMOs is nice to have
- Proven experience in managing and coordinating both internal and external deliverables.
- Demonstrated technical expertise in purification of recombinant proteins utilizing column chromatography and tangential flow filtration.
- Sound knowledge of cGMP practices as applicable to process development, scale up, technology transfer, formulation development and Manufacturing
- Proficiency in statistical software (JMP, R, etc) for data analysis and tracking and trending.
Travel, Physical Demands & Work Environment:
- Seeking Boston local candidates to be on-site 2-3 days per week.
- Manual dexterity required to operate office equipment (e.g. computers, phones, etc.).
- Typical office and laboratory bending, stooping, and lifting requirements.
- Willingness to travel to various meetings or client sites, including overnight trips.