Caribou Biosciences, Inc.
Associate Director of Quality Control
Caribou Biosciences, Inc., Berkeley, California, United States, 94709
Overview
Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company developing transformative therapies. We are advancing off-the-shelf, allogeneic cell therapies from our CAR-T cell platform for hematologic malignancies and autoimmune diseases. We are seeking an experienced and innovative Associate Director, Quality Control (QC) to lead key aspects of our QC strategy and operations. 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. 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 on-site expectation up to three days per week and 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 QC activities aligned with cGMP and project/business needs.
Compliance & Regulatory Support:
Act as QC SME for regulatory filings, inspections, committees, and change control; lead, review and approve investigations related to QC testing (OOS, OOT, deviations) 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 samples and trending; analyze QC data trends for continuous improvement; collaborate with QA, QS, Regulatory, Manufacturing, Analytical & Process Development, and Supply Chain; represent QC during regulatory inspections and external audits; present data and recommendations to technical and non-technical audiences.
People & Process Development:
Demonstrate readiness to lead and develop a growing QC team in the future; contribute to organizational design and workforce planning within Quality; support mentoring and onboarding of new team members; develop cross-functional project leadership and external partner/vendor oversight; maintain a strong quality mindset with data analysis, control charting, and process optimization (5S, Lean, Kaizen).
Required Qualifications
BS in Life Sciences or related field with 10+ years of 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
Proven 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
Compensation & Benefits
Comprehensive compensation package with salary, bonus, and equity
Salary Range: $187,000 to $200,000 (varies by location, skill, experience, and performance)
Generous paid vacation and company-observed holidays
Medical, dental, and vision insurance
401(k) with employer contributions; Employee stock purchase plan (ESPP)
Equal Opportunity & Compliance Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, disability, veteran status, sexual orientation, gender identity or expression, sex (including pregnancy and breastfeeding), genetic information, or other protected status. Legal authorization to work in the United States is required. All persons hired will be required to verify identity and work eligibility.
Notes We do not accept unsolicited resumes or candidate submissions from staffing agencies. Public and internal references to job alerts, application forms, and demographic surveys have been omitted to maintain focus on the role and its requirements.
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Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company developing transformative therapies. We are advancing off-the-shelf, allogeneic cell therapies from our CAR-T cell platform for hematologic malignancies and autoimmune diseases. We are seeking an experienced and innovative Associate Director, Quality Control (QC) to lead key aspects of our QC strategy and operations. 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. 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 on-site expectation up to three days per week and 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 QC activities aligned with cGMP and project/business needs.
Compliance & Regulatory Support:
Act as QC SME for regulatory filings, inspections, committees, and change control; lead, review and approve investigations related to QC testing (OOS, OOT, deviations) 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 samples and trending; analyze QC data trends for continuous improvement; collaborate with QA, QS, Regulatory, Manufacturing, Analytical & Process Development, and Supply Chain; represent QC during regulatory inspections and external audits; present data and recommendations to technical and non-technical audiences.
People & Process Development:
Demonstrate readiness to lead and develop a growing QC team in the future; contribute to organizational design and workforce planning within Quality; support mentoring and onboarding of new team members; develop cross-functional project leadership and external partner/vendor oversight; maintain a strong quality mindset with data analysis, control charting, and process optimization (5S, Lean, Kaizen).
Required Qualifications
BS in Life Sciences or related field with 10+ years of 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
Proven 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
Compensation & Benefits
Comprehensive compensation package with salary, bonus, and equity
Salary Range: $187,000 to $200,000 (varies by location, skill, experience, and performance)
Generous paid vacation and company-observed holidays
Medical, dental, and vision insurance
401(k) with employer contributions; Employee stock purchase plan (ESPP)
Equal Opportunity & Compliance Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, disability, veteran status, sexual orientation, gender identity or expression, sex (including pregnancy and breastfeeding), genetic information, or other protected status. Legal authorization to work in the United States is required. All persons hired will be required to verify identity and work eligibility.
Notes We do not accept unsolicited resumes or candidate submissions from staffing agencies. Public and internal references to job alerts, application forms, and demographic surveys have been omitted to maintain focus on the role and its requirements.
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