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 Scientist, 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:
- The candidate is expected to actively contribute to successful development, qualification and execution of robust analytical methods in support of company pipeline projects
- Manage activities at contract manufacturing organizations (CMO) and contract testing labs (CTL), including review and/or approval of test records/forms, protocols and reports, deviations/investigations, standard operating procedures (SOP) and certificates of analysis (COA)
- 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, including qualification and tech transfer of in-process methods, trouble-shooting and evaluating method performance during investigation of deviations
- Evaluate/select new technologies, instruments, reagents and perform necessary qualifications
- Ensure high-quality and timely documentation in laboratory notebook and development reports
- Draft and review SOPs, test records/forms, various analytical protocols and reports
- Analyze/summarize experimental data and present findings to scientists and management at technical and project sub-team meetings
- Work closely with Project Management, Regulatory Affairs and Quality to ensure project and regulatory filling timelines are met
- Perform other duties as assigned, such as lab maintenance, technology evaluation, equipment purchases and qualifications, order and stock lab supplies, etc.
The ideal candidate for this position will have demonstrated in-depth experience with hands-on execution and management of analytical development/QC function associated with the GMP production and testing of biologics in an industry setting.
- PhD or MS/BS in Biological Sciences or related scientific discipline, PhD preferred
- 2+ years (PhD), or 4+ years (MS) Biotech/Pharmaceutical industry experience, with a primary focus on analytical development of biologics required
- Experience developing and optimizing viral infectivity assay highly desirable, experience working with adenovirus is a plus
- Experience developing and optimizing cell-based potency assays highly desirable
- Experience working with general vaccine analytical methods (such as CE, ELISA, qPCR, impurity assays) development and optimization desirable
- Experience working with plasmids in a pharmaceutical setting desirable
- Experience in analytical method qualification, validation and technology transfer to QC lab desirable
- Knowledge of GMP and FDA/ /ICH/ /USP regulations, as well as solid understanding of instrument/method validation (21CFR11 and ICHQ2) desirable
- Good laboratory practice is a must
- Strong planning/organizational skills and attention to detail
- Ability 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)
- Experienced in using statistical and DOE software in analytical method development