Caribou is a leading clinical-stage CRISPR genome-editing biopharmaceutical company founded by pioneers in this field. Leveraging our proprietary technologies, we are developing genome-edited, off-the-shelf immune cell therapies for the treatment of patients with devastating human diseases, including cancer. We believe that cell therapies are critical now and for the future of cancer therapeutics, and that advanced genome editing is necessary to develop sophisticated cell therapies to treat a variety of malignancies. We are developing a pipeline of wholly-owned, genome-edited, off-the-shelf CAR-T and CAR-NK cell therapy product candidates for a range of tumor types. Caribou’s headquarters are in Berkeley, California.

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, their contributions are recognized, and their needs are met.

Our fun and collaborative Analytical Development team is seeking an innovative and highly motivated Director with expertise in cell therapy to lead the Analytical Development efforts for Caribou’s gene-edited cell therapies. Reporting to the VP of Technical Operations, you will oversee the development of sensitive and robust analytical test methods to support release testing and characterization of investigational cell therapy products. While guiding and mentoring a team of AD researchers, you’ll use your AD expertise to transfer and advance our pipelines into clinical trials. It’s a great opportunity to make a direct impact on the quality of saving the lives of patients.

Responsibilities include:

  • Lead and grow internal analytical development team to ensure members have appropriate resources and training to achieve product development goals
  • Ensure that testing methodologies meet phase-appropriate cGMP requirements
  • Participate in specification setting for critical materials and drug products
  • Work with internal subject matter experts to write and review analytical test method protocols and development reports
  • Oversee technical transfer of novel test methods to CMOs/CTOs/CROs for GMP/GLP testing
  • Review method qualification/validation plans and reports by external vendors
  • Design stability programs at CMOs/CTOs/CROs
  • Author and review analytical CMC modules to support regulatory filings
  • Serve as an AD subject matter expert within department and cross-functional areas
  • Interact with cross-functional research and development teams to determine the appropriate testing methodologies to support company strategies
  • Oversee development of sensitive and robust analytical test methods to support release testing and characterization of investigational cell therapy products

Qualifications:

  • BS degree in the life sciences with a minimum of 12 years analytical development and quality control experience; MS or PhD with a minimum of 6 years applicable experience
  • Extensive experience managing CMOs/CTOs
  • Expertise with analytical method tech transfer and qualification/validations
  • Extensive knowledge and hands-on experience with validation of cell-based potency assays
  • Extensive knowledge of ICH guidelines for method validation
  • Experience in authoring analytical modules of CMC sections of INDs
  • Working knowledge of cGMP regulations and guidelines is essential
  • Ability to manage CMO/CRO interactions and build/maintain professional and productive relationships
  • 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

Nice-to-haves:

  • Experience in a start-up environment
  • Experience with product launch activities including authoring of BLA or MAA
  • Knowledge of current best practices for potency assays for cellular therapies
  • Background in immuno-oncology or cell engineering

Caribou compensation and benefits include:

  • Comprehensive compensation package, which includes stock options and an employee stock purchase program for all employees
  • 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
  • Tuition reimbursement program

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, including a booster shot, 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.

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