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Pleasanton CA

Research Associate, Product Development

Research Associate, Product Development

Position Summary:

This role is an exciting opportunity to join Gritstone to develop processes for the manufacture of mRNA- based personalized vaccine vectors. The successful candidate will have familiarity with nucleic acid therapeutics and must have hands on experience in RNA transcription, enzymatic capping and purification. The incumbent may also work with CMOs for plasmid manufacture and cell-culture development for viral vectors. Ability to work in a fast-paced, interdisciplinary environment is essential. 

  • Must have experience with RNA synthesis by in-vitro transcription and nucleic acid purification
  • Must have experience with primer design, plasmid DNA preparation, and amplification (qPCR) 
  • Experience with immunoassays and gel electrophoresis 
  • Experience with nucleic acid characterization with UV absorbance and capillary electrophoresis
  • Experience with robotic liquid handlers 
  • Experience with tech transfer of processes to manufacturing is desirable. Must be willing to don clean room gowning to assist manufacturing in process tech transfer and troubleshoot manufacturing issues
  • Experience with nucleic acid sequencing – NGS experience is desirable
  • Experience with mammalian cell culture is a plus 
  • General laboratory assistance including lab equipment maintenance, ordering and receiving of lab supplies, preparation of reagents and compliance with safety policies
  • Closely collaborate with other departments throughout the company as well as external research and manufacturing organizations
     

Minimum Education/Experience:

  • B.S. / M.S in Molecular Biology or a related field with 3-5 years of experience
  • Experience with cGMP regulations and requirements is desirable
     

Other Qualifications:

  • Strong analytical thinking and ability to troubleshoot process issues
  • Self-motivated, self-disciplined and able to function independently as well as part of a team
  • Strong ability to prioritize, multi-task, and work in an evolving environment
  • Good written/verbal communication skills. Must be able to present results at internal meetings
  • Excellent computer proficiency (MS Word, Excel, PowerPoint, Visio)

Manufacturing Associate II/III

Manufacturing Associate II/III

Position Summary:

Gritstone Oncology is a cancer immunotherapy company developing next-generation personalized cancer therapeutics. The company’s initial goal is to identify and deploy therapeutic neoantigens from individual patients’ tumors to develop novel treatments for cancer.


The Manufacturing Associate will execute activities associated with cell culture manufacturing in a clean room environment. Processes will be focused on viral vector based cancer vaccine products. This role will also need to assist with purification, fill, and buffer prep processes as well as maintain material inventory in labs.  
 

Summary of Essential Job Functions:

  • Possess experience and expertise in cGMP manufacturing environment.
  • Possess experience and subject matter expertise in mammalian cell culture, thawing cells, passaging cultures, counting cells, and transfection. 
  • Possess experience maintaining cell lines in small to medium scale bioreactors.  
  • Possess knowledge of purification and aseptic fill processes.
  • Responsible for day to day manufacturing activities including but not limited to stocking of materials, preparation of documentation, cleaning and sanitization of parts, rooms and equipment, operation of process equipment.
  • Ability to document activities in accordance with cGMPs
  • Follow accurate verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation
  • Maintain cleanliness and orderliness of operational area
  • Ability to identify process and quality problems and follow corrective actions
  • Demonstrate knowledge and understanding of GMPs and how they apply to specific responsibilities
  • Maintain a safe working environment
  • Follow company policies and procedures
     

Minimum Education/Experience:

The ideal candidate for this position will have demonstrated in-depth experience with cell culture in GMP manufacturing within a cleanroom environment.

  • BS in Biological Sciences or related scientific discipline
  • 2 – 4+ years in a cGMP manufacturing environment
  • Must be able to pass aseptic gowning and aseptic processing qualification and have ability to work in cleanroom for up to 8 hours a day.
  • Must be able to adjust to flexible work schedule including weekend work.
  • Must be able to execute process steps according to defined SOPs and batch records.
  • Knowledge of GMP and regulatory requirements preferred
  • Experience in lean manufacturing, continuous improvement, Kaizen, 5S a plus.
  • Experience with plasmid construction and expansion a plus
     

Other Qualifications:

  • Manual dexterity
  • Ability to lift items up to 50 lbs
  • 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.
  • 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)