Director of Process Development

165 - Process Development · Berkeley, California
Department 165 - Process Development
Employment Type Full-Time
Minimum Experience Executive

Caribou Biosciences is a clinical-stage biopharmaceutical company founded in 2011 by pioneers in CRISPR genome editing and headquartered in Berkeley, California. The company’s mission is to develop innovative, transformative therapies for patients with devastating diseases through novel genome editing. Caribou leverages its proprietary technologies to develop a wholly owned pipeline of genome-edited, off-the-shelf immune cell therapies, including CAR-Ts and CAR-NKs, for the treatment of multiple different types of cancer. Caribou believes that advanced genome editing is necessary to develop sophisticated cell therapies to treat a variety of malignancies.

 

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 Process Development team is seeking an innovative and highly motivated scientific director with expertise in cell therapy manufacturing to lead the process development efforts for Caribou’s gene-edited cell therapies.  Reporting to the VP of Technical Operations, you will develop the manufacturing process for multiple gene-edited cell therapeutic products while guiding and mentoring a team of PD Engineers and Associates. You’ll oversee Manufacturing Operations, which includes managing the technical transfer of manufacturing processes to Contract Manufacturing Organizations (CMOs), as well as GMP manufacturing oversight of clinical trial materials including batch record review, impact assessments on Deviations, Investigations, CAPAs, and Change Controls related to the manufacturing process. Your expert guidance will lead to solutions that will quickly be implemented into the manufacturing process and have a direct impact on the patient. 

 

Responsibilities:

  • Lead all Process Development efforts for preclinical and clinical cell therapy programs
  • Manage and grow a team of PD engineers and associates
  • Optimize cell culture, gene editing, cell purification, formulation, and related processes to increase manufacturing yields while preserving potency
  • Use engineering principles to leverage bench and pilot scale models for process performance characterization
  • Participate in the identification and selection of cGMP CMO partners
  • Transfer technologies to CMOs and provide training and on-going technical support
  • Design characterization studies, evaluate product impact of scale-up and/or raw material changes, and apply scientific and engineering fundamentals to investigate non-conformance and develop corrective and preventive actions
  • Optimize scale-up of operations with quality by design principles
  • Generate development reports and review and approve SOPs and batch records
  • Plan and oversee process validation activities at CMOs
  • Contribute to the design of analytical methods for product characterization and release
  • Author CMC sections of regulatory filings including supporting documents, reports and change controls
  • Represent PD in cross-functional teams, working in a highly matrixed team environment to advance preclinical programs
  • Plan for and oversee execution of process validation studies to support commercial launch of allogeneic CAR-T cell therapies

 

Qualifications:

  • PhD or Master’s degree in Cell Biology, Immunology, Biochemistry, Bioengineering, Molecular Biology or a related field, or Bachelor’s degree with commensurate relevant work experience
  • Minimum of 7 years of process development experience for biologics (cell therapy preferred)
  • Experience managing an internal Process Development team
  • Intimate understanding of current good manufacturing practices
  • Extensive experience managing cell-based process development and technology transfer
  • Direct experience managing CMO interactions and building productive relationships
  • Experience with DOE studies, advanced statistical analysis and QBD principles
  • Excellent verbal and written communication skills
  • Proven ability to manage teams, as well as to collaborate with peers and work effectively in a fast-paced team-oriented environment
  • Strong organizational, time management, communication, and interpersonal skills
  • Embodies the company culture of justice, empowerment, diversity, and inclusion
  • Ability to travel up to 10%

 

Nice-to-haves (but not required):

  • Direct hands-on experience manufacturing CAR-T cells
  • Experience with gene engineering techniques
  • Experience with viral transduction systems and viral manufacturing
  • Experience with iPSC development and production
  • Experience with late stage clinical or commercial manufacturing
  • Experience with BLA filing
  • Experience interacting with corporate partners
  • Background in immunology or immune cell engineering or developmental biology

 

 

Caribou Biosciences, Inc. is a dynamic start-up biotechnology company, and the successful candidate should have a passion for science and a desire to work in a collaborative environment. Caribou promotes a culture in which employees are respected and valued for hard work, innovation, personal initiative, and teamwork.  

 

Caribou compensation and benefits:

 

  • Comprehensive compensation package including stock options
  • Generous paid vacation time in addition to Company-observed holidays
  • Excellent medical, dental, and vision insurance
  • 401(k) retirement savings plan including matching employer contributions
  • Tuition reimbursement program

 

Caribou is an equal opportunity employer and does not discriminate on the basis of 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 U.S. 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. 

 

For more information, please visit www.cariboubio.com. Caribou is on Twitter. Follow the Company @CaribouBio.

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  • Location
    Berkeley, California
  • Department
    165 - Process Development
  • Employment Type
    Full-Time
  • Minimum Experience
    Executive