Associate Director of Quality Control

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 activity against diseases. 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 cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases.

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.

Caribou is seeking an experienced and innovative Associate Director, Quality Control (QC), to lead key aspects of our QC strategy and operations. Reporting to the VP of Quality, this individual contributor will oversee QC testing and data management programs, serve as a key interface with contract labs and manufacturing partners, and ensure compliance with global regulatory standards. While this is currently an individual contributor role, the ideal candidate will demonstrate strong leadership potential and the ability to grow into a people management role as the QC function expands. This hybrid position is based in Berkeley, CA, with an expectation of being on-site up to three days per week, with flexibility as needed.

Key Responsibilities

Specifications & Release

• Lead the development, review, and approval of raw material, in-process, and drug product specifications
• Generate, review and approve Certificates of Analysis (CoA) and Certificates of Test (CoT)
• Represent QC in Specification Review Committees and ensure alignment across functions

Testing & Partner Oversight

• Oversee QC testing conducted at internal and external labs (CDMOs, CTLs)
• Provide QC leadership for analytical tech transfers and method qualifications
• Ensure timely, phase-appropriate execution of QC activities in alignment with cGMP and project/business needs

Compliance & Regulatory Support

• Act as QC SME for regulatory filings, inspections, committees, and change control processes
• Lead, review and approve investigations (as they relate to QC testing: OOS, OOT, deviations, etc.) and associated CAPAs
• Support implementation and oversight of compliant electronic systems (e.g., LIMS, ELN)

Stability & Data Management

• Design and manage stability programs compliant with ICH guidelines
• Oversee retain/reserve sample and trending programs
• Analyze QC data trends to identify areas for continuous improvement

Collaboration & Communication

• Collaborate with cross-functional stakeholders including QA, QS, Regulatory, Manufacturing, Analytical & Process Development, and Supply Chain.
• Represent QC during regulatory inspections and external audits
• Present data and recommendations clearly to technical and non-technical audiences

Team Growth & Leadership Potential

• Demonstrate readiness to lead and develop a growing QC team in the future
• Contribute to organizational design discussions and workforce planning within the Quality function
• Support mentoring and onboarding of new team members as needed

Key Competencies

• Technical Expertise in cell therapy QC
• Cross-functional Project Leadership
• External Partner and Vendor Oversight
• Regulatory Intelligence and Compliance (FDA, EMA, ICH, Data Integrity)
• Data Analysis, Trending, control charting (LIMS, SPC, Excel, PwrPt., JMP or equiv).
• Scientific Rigor and Quality Mindset
• Optimization and Efficiency: 5S, Lean, and Kaizen
• Effective Written (incl. technical) and Verbal Communication (incl. presenting in person and virtual meetings)
• Leadership Potential and Talent Development

Required Qualifications

• BS in Life Sciences or related field with 10 years QC/analytical experience in biologics, cell therapy, or gene therapy; or MS/PhD with 6 years of relevant experience
• Deep experience in specification management, analytical method transfer, stability programs, and regulatory submission support
• Strong working knowledge of cGMPs, 21 CFR Part 11, and global regulatory requirements
• Demonstrated ability to lead cross-functional projects and readiness to grow into people management
• Experience managing CDMOs/CTLs and navigating regulatory inspections

Preferred Qualifications

• Experience in a clinical-stage or start-up biotech environment
• Experience authoring CMC sections of BLAs or MAAs
• Knowledge of potency assays and immuno-oncology assays
• Background in cell engineering or synthetic biology

Caribou compensation and benefits include:

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $187,000 to $200,000 - 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
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (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, hair texture or type 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.

We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc. for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc. will not be obligated to pay any referral or placement fee.