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 Research associate, Analytical Development will execute activities associated with the development, optimization and qualification/validation of analytical methods 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, production, engineering and process development to foster effective communication, technology transfer and achievement of corporate goals between groups.
Summary of Essential Job Functions:
- Under supervision of scientists, the candidate is expected to contribute to method development, optimization and qualification of various analytical methods and provide analytical service support
- Perform analytical procedures in support of characterization, lot release and stability testing of drug substance and drug products
- Provide analytical support for IND-enabling process development and manufacturing operations
- Evaluate/select new technologies, instruments, reagents and perform necessary qualifications
- Ensure high-quality and timely documentation in laboratory notebook and development reports
- Draft SOPs, test records/forms, various analytical protocols and reports
- Analyze/summarize experimental data and present findings at group meetings
- Perform other duties as assigned, such as lab maintenance, technology evaluation, equipment purchases and qualifications, order and stock lab supplies, etc.
- MS/BS in Biological Sciences or related scientific discipline
- 2+ years (MS), or 4+ years (BS) Biotech/Pharmaceutical industry experience, with a primary focus on analytical development and services of biologics required
- Hands-on experience with cell culture and analytical techniques for viruses highly desired, experience working with Adenovirus is a plus
- Experience in performing cell based potency assays desired
- Experience in performing ELISA based immunoassays desired
- Experience in performing RT-PCR, qPCR assays desired
- Experience in performing analytical procedures for proteins (such as SDS-PAGE, silver stain, western blot, UV spectrometry, BCA/Lowry) desired
- Experience working with HPLC desired
- Experience in molecular biology techniques with plasmids desired
- Good laboratory practice is a must
- Understanding of and experience with 21CFR11 and ICHQ2 is a plus
- Strong organizational skills and attention to detail
- Ability to work effectively in a fast-paced, small start-up company environment
- Self-motivated, able to function in a collaborative team environment
- 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)