SCIENTIST/SENIOR SCIENTIST, ANALYTICAL TECHNOLOGIES (BIOASSAY)

Analytical Development Pleasanton, CA


Description

Position Summary:

The Scientist/ Sr. Scientist will be a leading member in the Analytical Technologies group responsible for bioassay development, validation, transfer and execution at Gritstone Bio. The bioassays includes cell-based potency assay, ELISA, PCR-based assays, and virus infectivity assays, etc., that are used to support product characterization, release, stability study in GMP setting as well as other research projects for process, formulation and manufacturing development. This position will contribute to the strategy of selecting and implementing bioassays to ensure our products are comprehensively characterized and under superb quality control. With dedication to trouble-shooting and optimizing assays on bench, this position may lead a small group to achieve department goals. Excellent training and background in biological sciences, such as cell biology, molecular biology, biochemistry, immunology, virology, etc., is required. Biologics experience is preferred but not a must-have.

Responsibilities:

  • Independently select, develop, validate, and transfer biological assays including cell-based potency assays, ELIZA, qPCR-based assays, virus infectivity assays, etc.
  • Justify in front of a review panel that the bioassays are suitable for the intended use per appropriate regulatory guidelines
  • Evaluate new technologies and innovate bioassays to expand analytical capabilities of the group
  • Working knowledge of compliance requirements for bioassay development and validation as in guidelines published by FDA, ICH, EMA, USP, etc.
  • Working knowledge of GMP production of biologics including proteins, cell and gene therapy and relevant requirements of analytical methods used for GMP production of biologics
  • Experience in virus-vector based biotechnology or virology in general is preferred but not required
  • Perform analytical tests to support method development, DS/DP characterization, PD studies, lot release and stability testing of drug substance and drug products
  • Author method SOPs, development reports, qualification/validation reports to support method transfer to GMP QC
  • Trouble-shoot and optimize bioassays with hands-on work on bench
  • Manage analytical method development, qualification, validation, and transfer at CRO/CMO sites
  • Manage other CMC activities at CRO/CMO sites where Analytical Technologies group is involved
  • Represent the Analytical Technologies group in meetings with collaborators to help with the interpretation of data, selection of test methods, resource allocation and priority setting, etc
  • Train junior staff members
  • Other duties as assigned
Qualifications:
  • 10+ years of industry experience with a BS Degree in a relevant scientific discipline or 6+ years of industry experience with a Ph.D. degree
  • Experience in developing and validating biological assays in the pharmaceutical or biotech industry is essential. Experience with biologics is preferred.
  • Sound understanding and adequate skills in statistics
  • Excellent written and oral communication skills
  • Outstanding attention to detail
  • Ability to work independently and on teams
  • Strong time management skills
  • Personnel management and project management experience is preferred but not required

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 bio anticipates that the annual base salary for the Scientist level position could range between $116,000 - $148,000. The anticipated annual base salary for the Senior Scientist level position could range between $137,000 - $174,000. Compensation will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered salary is also based on internal equity, internal position salary ranges, and market data. The salary range listed does not include any applicable bonuses or long-term incentives, differential pay or other forms of compensation or benefits. Gritstone is a multistate employer and the salary offered will be market competitive. At Gritstone, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.

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.