Sr. Scientist, Upstream Process Development

Our vaccine client here in Boston, MA is looking to add a Sr. Scientist, Upstream Process Development (onsite) to support their recombinant vaccine program! Will be technical expert in microbial strain and fermentation process development and oversee the development of upstream technical activities (including microbial strain generation, fermentation/upstream process development) through the clinical development. The successful candidate will work in the laboratory as well as with CDMOs to ensure all aspects of the drug substance process development and manufacturing are completed according to Quality by Design principles and cGMP requirements.

Other Responsibilities include but not limited to:

• Design, development and establishment of fermentation and cell culture processes, procedures and technologies in the development of best-in-class vaccine
• Provide expertise for the scale up, optimization and tech transfer, and validation, of upstream cell culture and viral vector unit operations to internal and external partners in support of clinical manufacturing of vaccine products.
• Manage CDMOs for Upstream tech transfer timelines and deliverables.
• Provide technical assessment to enable selection of drug substance Contract Development and Manufacturing Organizations (CDMO).
• Accountable as technical subject matter expert for all upstream drug substance upstream activities supportive of clinical development and IND filing.
• Work closely with CDMO partners and technical team on process design, optimization and characterization, provide technical guidance, oversight, and troubleshooting to ensure CDMO partners successfully develop a robust/efficient process, ensure timely delivery of clinical materials as per required timeline and seamless paths towards successful regulatory submissions.
• Author and review CMC sections of regulatory submissions, technical reports crucial for filing and responding to questions from regulatory submissions.

Requirements:

• Master’s or PhD in Microbiology, Biochemistry, Chemical Engineering, Biotechnology, Pharmaceutical sciences or related field
• A minimum of 5 years’ experience (PhD) or MS and a minimum of 8 years’ experience developing upstream processes from microbially expressed recombinant proteins. Familiarity and experience with other expression platforms (insect and Mammalian) is beneficial but not necessary.
• 5+ years of industry experience, additional academic research in bacterial strain and fermentation process development preferred.
• Direct experience with recombinant VLPs or vaccines is highly desirable.
• Some experience working with CDMOs is a plus.
• Proven experience in managing and coordinating both internal and external deliverables.
• Demonstrated technical expertise in production of recombinant proteins utilizing microbial platforms is essential.
• Sound knowledge of ICH Q8 guidelines for pharmaceutical development and utilizing quality by design principles for developing robust, scalable upstream processes is required.
• Proficiency in statistical software (JMP, R, etc.) for data analysis, DOE, and tracking and trending and presenting data in project teams.
• Demonstrated ability to work efficiently across multiple project teams.

Other:

  • Seeking Boston local candidates to be on-site 3-4 days per week. 
  • Willingness to travel to various meetings or client sites, including overnight trips (up to 10%)