25 days old

DIRECTOR, PROCESS ENGINEERING

Gritstone Oncology
Pleasanton, CA 94588
  • Job Code
    121545968

The Director, Process Engineering will support process engineering efforts within the company for drug product 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 of manufacturing processes to accommodate rapid manufacture of smaller scale personalized vaccines as well as upscaling of off the shelf vaccines. Process engineering will support research, development, analytical technologies and manufacturing with contributions including: plasmid and SAM production and purification process optimization, LNP formulation and product fill, 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, closed-system evaluations and proposals, dose preparation development, alternate dose container closure and/or formulation development. 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 formulation development for LNPs with adequate stability under practical storage conditions
  • Lead process improvements toward closed-system, commercial compliant processes and reduced COGs
  • Structure and staff engineering department to have expertise in automation and bioengineering areas
  • 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
  • Assist Development with 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

  • PhD. in Chemical or Bio-Engineering
  • 8+ years of experience in pharmaceutical, biotechnology or medical device companies
  • 4+ years of corporate experience in team building and people management
  • 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
  • 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


PI121545968

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Posted: 2020-07-13 Expires: 2020-08-13

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DIRECTOR, PROCESS ENGINEERING

Gritstone Oncology
Pleasanton, CA 94588

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