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2 months ago

Boston, United States HireMinds Full time

Senior Scientist, Tech Transfers (Process Development)

Boston, MA


Our clinical stage vaccine client located here in Boston, MA is growing and looking to add a Sr. Scientist, Technology Transfer to their Process Development team (onsite 3-4 days/week) This role will be leading the tech transfers for early and late clinical phase drug substance/drug product, to both internal and external contract development & manufacturing (CDMO) companies. Will provide strong scientific leadership and subject matter expertise for all aspects of drug substance/drug product including technology transfer, process fit analysis, process modelling, raw material controls and aseptic process assurance/microbiological control. Sr. Scientist will also lead timely risk identification, communication and resolution and work in close collaboration with analytical development (AD), manufacturing science and technology (MSAT), quality control (QC), quality assurance (QA), regulatory affairs (RA), and internal/external manufacturing sites. Other responsibilities regarding the process design, development and scale up of VLP production process include but not limited to:


  • Technical support for ongoing clinical manufacturing, process troubleshooting to manufacturing activities such as supporting process related investigations, deviation resolution, corrective actions/preventative actions, and direct responsibility for process monitoring/control charting of manufacturing operations.
  • Review of technical documents and support for regulatory submissions (IND/IMPD, BLA/MAA) are other responsibilities.
  • Manage and lead clinical technical transfer process and ensure alignment with CMC schedule to meet program and company goals / metrics, as required.
  • Provide technical assessment to enable selection of drug substance/drug product Contract Development and Manufacturing Organizations (CDMO).
  • Perform facility fit analysis, process gap assessments, and establish operational control strategy for each new receiving site.
  • Review batch records, process validation protocols, change controls, and deviations to support GMP manufacturing throughout lifecycle of biologics pipeline in partnering with QA and operations as applicable.
  • Ensure appropriate data management, perform process monitoring and communicate operation status to management.
  • Identify issues and risks and lead cross functional team to identify and drive alignment on action/mitigation plan for path forward.
  • Lead continuous improvement of efficiency of technology transfer plans and work process and influence manufacturing sites to focus on improving efficiency of technology transfer processes.



Requirements:


  • Master’s or PhD in Chemical Engineering, Pharmaceutical sciences or equivalent. Ph.D. is preferred; AND 5+ years’ experience (Ph.D.) OR MS with a minimum of 8 years’ experience in scale up and tech transfer of GMP operations is required.
  • Direct experience with recombinant VLPs or vaccines is highly desirable.
  • Proven experience in managing and coordinating both internal and external deliverables.
  • Demonstrated technical expertise in recombinant protein expression and purification.
  • Knowledge of quality attribute measurement assays and application to troubleshooting product quality related discrepancies.
  • 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.



Other:


  • Seeking Boston local candidates to be on-site 3-4 days per week.
  • Willingness to travel to various manufacturing sites, including overnight trips (up to 20%).