Scientist I

5 days ago

Pleasanton, United States Gritstone bio Full time

**RESPONSIBILITIES**:

- Actively contribute to the successful development, qualification and execution of robust analytical methods in support of company pipeline projects
- Perform analytical procedures in support of characterization, lot release and stability testing of drug substance and LNP drug products
- Provide analytical support for IND-enabling process development and manufacturing operations, including qualification and tech transfer of in-process methods
- Evaluate/select new technologies, instruments, reagents and perform necessary method optimization and qualification
- Ensure high-quality and timely documentation in laboratory notebook and development and qualification 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
- Assist in lab investigations, CAPAs or deviations
- Perform other duties as assigned, such as lab maintenance, technology evaluation, equipment purchases and qualifications, order and stock lab supplies, etc.

**QUALIFICATIONS**:

- PhD in Biological Sciences or related scientific discipline
- 1+ (Scientist I) or 3+ (Scientist II level), Biotech/Pharmaceutical industry experience, with a primary focus on analytical development of biologics required
- Hands on expertise with at least one chemistry -based assay development required - HPLC/UPLC Mass Spec, Ribogreen assay, Capillary Electrophoresis etc
- Proven expertise in analytical method qualification and/or validation and technology transfer required
- Experience in developing assays for lipid nanoparticles and assessment of lipids highly desired
- Knowledge of method comparability requirements and performance of comparability assessment highly desired
- Experience in vaccine, DNA/RNA analytical method development and optimization desired
- Knowledge of product and process development of biologics/vaccines desired
- Knowledge of GMP and FDA/EMA/ICH/USP regulatory requirements desired
- Good laboratory practice and precision pipetting is a must

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
The well-being and safety of our employees is our top priority. Gritstone requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (fully remote or site-based). Fully vaccinated is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
Gritstone’s benefit package includes medical, dental, vision, life insurance, and paid parental leave. Employees are also eligible to enroll in the 401k plan, which includes a 4% company match with immediate vesting. Employees are eligible to enroll in benefits effective the first day of employment and the competitive Paid Time Off (PTO) begins accruing on the first day as well. The job offer also includes an equity grant and eligibility for annual refresh grants based on performance. Gritstone employees also benefit from an Employee Stock Purchase Plan (ESPP) and thirteen (13) designated paid holidays as well as two (2) personal days.
Gritstone bio is an Equal Opportunity employer, as such, recruiting is conducted in a fair and non-discriminatory manner without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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