Position Summary:

The Product Development Engineer will 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 Engineer will play a key role in designing processes and related equipment for cGMP manufacturing with an emphasis on QbD. The engineer will need to liaise with manufacturing to foster effective communication, enable technology transfer and trending manufacturing operations using statistical methods such as SPC, for continuous process improvement.

Summary of essential job functions

  • Possess experience and working knowledge in viral vectors – cell culture, purification and formulation

  • Must have experience in mammalian cell culture

  • Must have experience with Chromatography and TFF operations. Experience with Akta and Unicorn systems or other process control software is a plus.

  • Must be proficient in reading/creating P&ID for process equipment. Experience with CAD is desirable

  • Interact with vendors to design/scope and purchase equipment and assist in SAT/IOQ activities

  • Support process sampling plan to monitor process development activities and optimization through adequate sample archives

  • Assist in development efforts for process improvements toward closed-system, commercial compliant processes and reduced COGs

  • Integrate QbD guidelines into new processes. Experience with DoE is desirable.

  • Assist in development related FMEA and RCA with engineering, as necessary

  • Assist in Tracking and Trending program structure and reporting

  • Coordinate and write as appropriate technical reports on key development findings

  • SME for technology transfer to CMOs and in-house GMP manufacturing

  • Assists in troubleshooting process and equipment issues on the manufacturing floor. Must be willing and able to don clean room gowning to enter manufacturing areas

  • Support in creating SOPs and Batch records for new and existing processes

  • 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


Minimum Education/Experience

  • B.S. / M.S./Ph.D. in Chemical or Bio-Engineering

  • 2-5 years of corporate experience at pharmaceutical or biotechnology company

  • Experience in viral vectors or gene therapy is required

  • Experience in regulatory requirements for combined products with vaccines desired

  • Experience in GMP


Other Qualifications

  • Strong organizational skills and attention to detail

  • Able 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, Visio, PowerPoint)

  • Proficiency using JMPÒ DOE and statistical software, or equivalent required

  • Up to 25% travel required.