Analytical Development Associate/Scientist
Caribou Biosciences, Inc. is a leading company in CRISPR genome engineering located in Berkeley, CA. Caribou's tools and technologies provide transformative capabilities to therapeutic development, agricultural biotechnology, industrial biotechnology, basic and applied biological research. The six-year-old company has developed a best-in-class CRISPR genome engineering technology platform and has a leading intellectual property position.
We are seeking an Analytical Development Associate/Scientist to join our Technical Operations team in Berkeley. The ideal candidate will interact with team members across the organization and provide Analytical Development and QC support to the Company.
Responsibilities will include:
- Interact with cross-functional research and development teams to determine the appropriate testing methodologies to support company strategies
- Develop sensitive and robust analytical test methods to support release testing and characterization of investigational biologic drug products
- Write analytical test method protocols and development reports as part of analytical transfers
- Oversee technical transfer of novel test methods to CMO/CTO/CROs for GMP/GLP testing
- Review method qualification/validation plans and reports by vendors
- Act as primary liaison with outside testing contractors and review QC test results
- Contribute to authoring of CMC sections to support regulatory filings
- Serve as an analytical/QC subject matter expert within department and cross-functional areas
Candidate must possess:
- BS degree in the life sciences required, while an advanced degree (MS, PhD) is desired
- Minimum 4+ years of analytical development and quality control experience
- Experience with development and qualification of multi-color flow cytometric analyses
- Experience in designing and executing in vitro functional assays to characterize primary immune cells including, but not limited to, cytotoxicity assays, cytokine/chemokine measurements, and proliferation assessment
- Experience with analytical method qualification/validations and tech transfers in regulated environments
- Extensive knowledge and hands-on experience with cell-based potency assays
- Working knowledge of cGMP regulations and guidelines is essential
- Ability to manage CMO/CRO interactions and maintain professional and productive relationships
- Excellent organizational, prioritization and planning skills in a fast-paced team-oriented environment
- Ability to work independently on projects and initiatives internally and with external vendors
- Possess a sense of urgency; identify challenges and problems and take the initiative to identify solutions
- Experience in a start-up environment preferred
- Experience in authoring analytical modules of CMC sections in INDs
- Knowledge of current best practices for measurement of cytokines from cellular therapies and subject samples
- Background in immunology or immune cell engineering
- Experience developing and transferring gene engineering-based cell therapies toward GMP
Caribou Biosciences, Inc. is a dynamic start-up company, and the successful candidate must have the ability and desire to work in a fast-paced environment. For more information, please visit www.cariboubio.com. Caribou is on Twitter. Sign up to follow our Twitter feed @CaribouBio.
Caribou offers a comprehensive compensation package, as well as generous paid time off in addition to Company-observed holidays. The Company provides medical, dental, and vision insurance, along with a 401(k) retirement savings plan which includes matching employer contributions. Caribou promotes a culture in which employees are respected and rewarded for hard work, innovation, personal initiative, and teamwork.
Caribou is an equal opportunity employer and does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the basis listed above or any other characteristics protected under federal, state, or local laws.
Direct applicants only. No agencies please