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 Senior 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:
- Possess experience and expertise in cGMP manufacturing environment.
- Possess experience and subject matter expertise in vector production –cell culture, purification, formulation, and fill both benchtop and small to medium scale.
- Experience in purification with AKTA systems a plus.
- Experience with plasmids a plus.
- Responsible for day to day manufacturing activities including stocking of materials, preparation and review of documentation, cleaning and sanitization of rooms and equipment, operation of process equipment, process development, validation activities.
- 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.
- Author SOPs, batch records, and review Validation Reports.
- Author deviations, change controls, CAPAs, and reports; possess understanding of quality systems.
- Assist in managing activities at contract manufacturing organizations (CMO) including review and/or approval of batch records and deviations/investigations
- Actively contribute to successful development, qualification, and execution of robust manufacturing processes in support of company pipeline projects
The ideal candidate for this position will have demonstrated in-depth experience with GMP production.
- BS in Biological Sciences or related scientific discipline
- Knowledge of GMP and regulatory requirements required
- 4 years or more in a cGMP manufacturing environment
- 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)