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Senior Director of Quality Control

Hybrid, Berkeley, California, United States

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 Biosciences is seeking an experienced and motivated Senior Director of Quality Control (QC) to lead and expand our QC function within the Technical Operations team. This is a pivotal role as Caribou advances its programs toward commercialization. The Senior Director will ensure the compliance and integrity of our GMP products and materials, develop robust QC strategies, and foster collaboration with internal teams and external partners, including CDMOs and CTLs. This role reports to the Vice President of Technical Operations.

Responsibilities:

  • Lead and execute QC strategy, managing the internal QC team and external testing partners
  • Develop, review, and approve specifications for drug products and critical materials to ensure regulatory compliance
  • Oversee stability programs and establish expiry dates for materials and products
  • Collaborate with Quality Assurance (QA) to develop and maintain QC-related SOPs
  • Review and approve QC test results, Certificates of Analysis, SOPs, deviations, change requests, and CAPAs
  • Drive validation strategies for analytical methods across Caribou’s programs
  • Represent QC in cross-functional meetings, contributing to program and operational decisions
  • Implement and maintain a LIMS system to streamline QC data tracking and ensure data integrity
  • Build and maintain robust data integrity practices company-wide

Qualifications:

  • Bachelor’s degree (BS) or higher in a STEM field
  • 15+ years of experience in Quality Control within the biopharmaceutical industry, including 5+ years managing QC laboratories
  • Significant experience in analytical method validation (10+ years)
  • Expertise in Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP) regulations
  • Strong leadership, communication, and interpersonal skills, with a demonstrated ability to lead cross-functional teams
  • Proven ability to thrive in a fast-paced, team-oriented environment with excellent organizational and prioritization skills
  • Proficiency in identifying challenges, developing solutions, and implementing them effectively
  • Knowledge of statistical methods and experience using statistical analysis software
  • Hands-on experience implementing and managing LIMS systems
  • Excellent organizational, prioritization and planning skills in a fast-paced team-oriented environment
  • Ability to work independently on multiple projects internally and with external vendors
  • Possess a sense of urgency; identify challenges and problems and take the initiative to identify solutions

Preferred Qualifications

  • Experience in QC for cell therapy products
  • Familiarity with laboratory equipment and software qualification
  • Expertise in flow cytometry and cell-based potency assay qualification
  • Exceptional technical writing skills, including SOPs, protocols, and validation reports

Caribou compensation and benefits include:

  • Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
  • Salary Range: $265,000 to $280,000- 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 and floating 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, 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.

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