Senior Scientist 1, Analytical Development

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve antitumor activity. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T and CAR-NK platforms as readily available treatments for patients with hematologic malignancies and solid tumors.

Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.

We are seeking an Analytical Development, Senior Scientist to join our Technical Operations team in Berkeley. The ideal candidate will collaborate cross-functionally, provide hands-on method development support, transfer methods, and work with biomarkers and interact with internal project team members across the organization to provide Analytical Development support to the Company. This role will report to the Director of Analytical Development and will be primarily on-site at our facility in Berkeley, CA.

Responsibilities will include:

• Develop sensitive and robust analytical test methods to support release testing, stability and characterization of investigational cell therapy drug products
• Maintain flow cytometry and cell sorting instruments as the subject matter expert, including regular preventative maintenance, qualification, software update, data backup, SOP development, and staff training
• Strong understanding of ICH and other guidelines supporting the development, transfer, qualification and validation of analytical test methods
• Developing analytical methods and validating ddPCR assays
• Act as AD liaison with external CRO/CDMO testing contractors
• Knowledge of GMP and regulatory requirements applicable to cell and gene therapy drug products
• Review method qualification/validation plans and reports by vendors
• Serve as an analytical subject matter expert within department and cross-functional groups

Qualifications:

• PhD in the life sciences with 5+ years of experience
• Industry experience in Analytical Development is required
• Experience developing analytical methods for Cell-Based Potency Bioassays
• Technical expertise in Multi-Color Flow Cytometry and ability to troubleshoot
• Experience with analytical method qualifications and tech transfers in regulated environments
• Experience with instrument qualification, troubleshooting, and preventative maintenance
• Experience with biomarker analysis
• Understanding of ICH Q2 principles
• Excellent organizational, prioritization and planning skills in a fast-paced and team environment
• Ability to work independently, take ownership, and initiate novel projects
• Demonstrated ability to work in cross-functional teams
• Knowledge of basic statistics and DOE
• Experience in authoring analytical modules of CMC sections in INDs
• Experience working in/with laboratories that support cell therapy products
• Strong writing, documentation, and electronic notebook skills

Nice-to-haves:

• Experience with biomarker analysis
• Experience in authoring analytical modules of CMC sections in INDs

Caribou compensation and benefits include:

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $150,000.00 to $175,000.00 - This represents the present low and high end of the Company's pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance.
• Generous paid vacation time, in addition to company-observed holidays and floating holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase program (ESPP)
• Tuition reimbursement program

The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.

Caribou is an equal opportunity employer and does not discriminate based on 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 bases listed above or any other characteristics protected under federal, state, or local laws.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Caribou requires employees to be fully vaccinated against COVID-19 unless they have an approved medical or religious accommodation. Proof of such vaccination will be required as part of the hiring process.

For more information about Caribou, visit www.cariboubio.com and follow the company @CaribouBio.