Our vaccine client here in Boston, MA is growing and looking to add a Sr. Scientist, MSAT Upstream to their team (Hybrid onsite/WFH)! This role will support the tech transfer and process development through the application of processes, procedures and technologies in the development of best-in-class vaccine scale up and manufacturing. Provide expertise for the scale up, tech transfer, and validation, of upstream cell culture and viral vector unit operations to internal and external partners in support of clinical/commercial manufacturing of products. Sr. Scientist will also manage CDMOs for Upstream tech transfer timelines and deliverables and act as a cross-functional subject matter expert in the organization to promote scientific and operational excellence. Other responsibilities include but not limited to:
- Development and execute lab studies to support life cycle management and continuous improvement initiatives.
- Drive process characterization studies to map design space (PARs and NORs) at the CDMOs.
- Working with internal resources to identify potential improvements for existing upstream processes.
- Perform gap assessments and design mitigation plans and studies in collaboration with CDMOs to derisk Manufacturing runs.
- Trend process data for ongoing batches and communicate to senior leadership.
- Assess process data and develop and/or recommend product specification ranges.
- Serve as a subject matter expert for Upstream unit operations to both internal and external stakeholders.
- Support ongoing technical transfer and manufacturing at CDMOs through acting as person in 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.
- Overseeing, developing, and managing external and internal cross-functional activities required to advance manufacturing goals.
- Supporting development and commercial operations groups in the preparation of relevant regulatory filings.
- Generate criticality assessments, Product quality risk assessments and lead FMEAs at the CDMO to support large scale tech transfer cross functionally.
Requirements:
- Masters or PhD in Chemical Engineering, Pharmaceutical sciences or equivalent. PhD is preferred.
- A minimum of 5 years experience (PhD) or MS and a minimum of 8 years experience in mammalian or insect cell culture for the production of VLPs or other similar recombinant proteins.
- Direct experience with recombinant VLPs or vaccines is highly desirable.
- Some experience working with CDMOs is preferable.
- Demonstrated technical expertise in production of recombinant proteins utilizing transient or stable transfections in mammalian or insect cell lines.
- 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, DOE, and tracking and trending.
- Demonstrated ability to work efficiently across multiple project teams and business functions.
Other:
- Seeking Boston local candidates to be on-site 2-3 days per week.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Up to 10-20%