Scientist II/Sr. Scientist, Product Development

Position Summary

Reporting to the Director of Process Development, the Product Development Scientist will work in the Process Development department to assist and/or lead select development efforts within the company to support all Gritstone drug product manufacturing processes. Processes will vary in substance and composition, but will initially be focused on viral vector and nucleic acid based cancer vaccine products. The PD scientist will play a key role in developing processes for cGMP manufacturing with an emphasis on QbD. This role will need to liaise with research, production, engineering and analytical technologies to foster effective communication, technology transfer and achievement of corporate goals between groups.  This role may need to manage daily operations of development laboratories and staff.  This position will also assist Director of Development and Engineering to estimate resource needs, develop budgets, manage facility needs and create timelines

Summary of essential job functions

  • Possess experience and working knowledge in adenoviral vectors –cell culture, adenovirus purification and formulation.
  • Possess experience and working knowledge in mRNA therapeutic vaccine candidate and formulation. Experience with lipid nanoparticle formulations is highly desirable.
  • Must be proficient in recombinant DNA technology methods like cloning, gel-electrophoresis, PCR, qPCR, ELISA, Northern and Southern Blotting.
  • Support process sampling plan to monitor process development activities and optimization through adequate sample archives
  • Perform/direct evaluation and selection efforts to identify candidate MCB and WCB
  • Assist in development efforts for process improvements toward closed-system, commercial compliant processes and reduced COGs
  • Coordinate development activities with analytical technologies to support product comparability and potential in-process control assay development
  • Generate publications on process improvements and technologies integration
  • Lead and coordinate staff career development efforts
  • Lead formulation development and cryopreservation and CRF candidate evaluations and optimizations
  • Integrate QbD guidelines into new processes
  • Assist in development related FMEA and RCA with engineering, as necessary
  • Assist in Tracking and Trending program structure and reporting
  • Participate in Gritstone’s multidisciplinary project teams to development activities
  • Coordinate and write as appropriate technical reports on key development findings
  • SME for technology transfer to CMOs and in-house GMP manufacturing
  • Support Regulatory Affairs to prepare, file and maintain appropriate regulatory body documents
  • Assist Project Management to determine development activities, timelines and resource needs to meet corporate goals
  • Assist in generation of timetables and budgets for development activities
  • As necessary, assist corporate development to support contracts and other legal documents to execute work plans and projects
  • As necessary, support Gritstone legal representatives to file and prosecute Gritstone intellectual property

Minimum Education/Experience

  •  Ph.D. in Life Sciences, Chemical, Mechanical or Bio-Engineering, or B.S. / M.S with equivalent experience
  •  8 years or more corporate experience at pharmaceutical or biotechnology company
  • 5 years or more corporate experience in team building and management
  • Experience in vaccine therapy and plasmid development and CMC regulatory knowledge required
  • Experience in regulatory requirements for combined products with vaccines desired
  • Experience in vaccine analytical methods filings desired

Other Qualifications

  • Strong organizational skills and attention to detail
  • Ability to work effectively in a fast-paced, small start-up company environment
  • Self-motivated, self-disciplined and able to function independently as well as part of a team
  • Strategic agility, strong critical and logical thinking with ability to analyze problems
  • Strong ability to prioritize, multi-task, and work in an evolving environment
  • Excellent presentation and written/verbal communication skills
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)
  • Proficiency using JMPÒ DOE and statistical software, or equivalent required
  • Up to 25% travel required, some international