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
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
- 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)