Job Description:

Senior Scientist, MSAT UpstreamBoston, MAOur vaccine client here in Boston, MA is looking to add a Sr. Scientist, MSAT Upstream (onsite) to support their recombinant vaccine program! This role will be key in supporting vaccine tech transfer and process development. You will provide expertise for the scale-up, tech transfer, and validation of upstream cell culture and viral vector unit operations in support of clinicalcommercial manufacturing.Responsibilities:Develop 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 CDMOsWorking 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 runsTrend process data for ongoing batches and communicate to senior leadershipAssess process data and develop andor recommend product specification rangesServe 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 QualityProviding technical input to the Quality organization with regards to CAPAs as neededOverseeing, developing, and managing external and internal cross-functional activities required to advance vaccine 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.Education, Experience & Skills: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 a nice to haveDeveloped leadership skills and the ability to communicate business objectives as well as technical information effectively.Proven experience in managing and coordinating both internal and external deliverables.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 trendingDemonstrated ability to work efficiently across multiple project teams and business functions.Other:On-site 2-3 days per weekWillingness to travel to various meetings or client sites, including overnight trips (domestic and international). Up to 10-20%