The Senior Manager/Associate Director, Process Development will support process development/ engineering efforts within the company for drug substance manufacturing processes. Processes will be focused on vaccines that are based on self-amplifying mRNA (SAM) formulated in lipid nano particles (LNP) for application in oncology and infectious diseases. Responsibilities include down-scaling and automation of manufacturing processes to accommodate rapid manufacture of smaller scale personalized vaccines as well as up-scaling of off the shelf vaccines. Process development will support research, analytical technologies, and manufacturing with contributions including: plasmid and SAM production and purification process optimization, quant and cost modeling, lean analysis, formal FMEA and RCA, data tracking and trending with report generation, JMP® supported statistical analyses, predictor profiling and DOE.
In addition, engineering will have substantial input toward facility layout and design, device and technologies assessment and integration, automation, and closed-system evaluations and proposals. As such, this position will oversee process engineering presentations and publications as well as provide technical guidance and input for timely patent filings and prosecutions.
Summary of essential job functions
Continually seek and evaluate new potential technologies for rapid production and purification of plasmids and SAM Lead process improvements toward closed-system, commercial compliant processes, and reduced COGs Contribute technical input into in-house GMP facility selection, design, and layout Lead quant modelling for manufacturing process Lead process engineering efforts including lean analysis, process device design, creation, and implementation Lead FMEA and RCA efforts for all departments Lead Tracking and Trending program structure and reporting Implement T&T application to support process optimization and in-process testing guidance Develop sampling plan creation, logistics, and use Coordinate and write technical reports on key development findings Support Regulatory Affairs to prepare, file, and maintain appropriate regulatory body documents Assist project management to determine engineering activities, timelines, and resource needs to meet corporate goal 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 Company intellectual property
Minimum Education & Experience
MS or PhD. in Chemical, Bio-Engineering or Biochemistry 8+ years (PhD) or 10+ years (MS) of experience in pharmaceutical, biotechnology or medical device companies Corporate experience in team building and people management is a plus Experience in vaccines or biologics development, production and CMC regulatory knowledge required Expertise in plasmid and mRNA production required Automation experience with lab equipment highly desired Experience in regulatory requirements for combined products with vaccines desired
Other Qualifications
Strong organizational skills and attention to detail Able to work effectively in a fast-paced, small start-up company 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 Excellent computer proficiency (MS Word, Excel, PowerPoint) Proficiency using JMP DOE and Statistical software, or equivalent required Up to 15% travel required