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
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
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.