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 neo-antigens from individual patients’ tumors to develop novel treatments for lung cancer.

The Manufacturing Associate will execute activities associated with manufacturing, as well as, development, optimization and qualification/validation in support of 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. This role will need to liaise with research, process development and Quality Assurance to foster effective communication, technology transfer and achievement of corporate goals between groups. 

Summary of Essential Job Functions: 

  • Responsible for day to day manufacturing activities including stocking of materials, preparation of documentation, cleaning and sanitization of rooms and equipment, operation of process equipment
  • Stock production area with supplies
  • 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
  • Execute process steps according to defined SOPs and batch records
  • Document activities in accordance with cGMPs
  • Follow accurate verbal and written procedures in operating production equipment and performing processing steps; accurately complete appropriate production documentation
  • Maintain cleanliness and orderliness of operational area
  • Actively contribute to successful development, qualification and execution of robust manufacturing processes in support of company pipeline projects
  • 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

Requirements:

The successful candidate for this position will have demonstrated in-depth experience with GMP production. In addition, the candidate should have the following education/experience;

  • BS in Biological Sciences or related scientific discipline
  • 0 - 2 years or more in a cGMP manufacturing environment
  • Knowledge of GMP and regulatory requirements preferred

Other Qualifications:

  • Ability to lift items up to 35 lbs
  • Manual dexterity
  • 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
  • Excellent presentation and written/verbal communication skills
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)