Senior Manager/Associate Director of Process Development

165 - Process Development · Berkeley, California
Department 165 - Process Development
Employment Type Full-Time
Minimum Experience Senior Manager/Supervisor

Caribou Biosciences, Inc. is a leading clinical-stage CRISPR genome engineering biotechnology company located in Berkeley, CA. Caribou's tools and technologies provide transformative capabilities to therapeutic development and the company is advancing an internal pipeline of genome-edited cell therapies for various oncology indications. The eight-year-old company has developed a best-in-class CRISPR genome engineering technology platform and has a leading intellectual property position. At Caribou, every employee is valued for their unique perspective, background, and diversity. Every person on the Caribou team contributes to problem solving and innovation. The Company’s vision is to advance agile genome editing innovations for the benefit of our communities.


The Company is seeking an innovative and highly motivated scientist with expertise in cell therapy manufacturing to lead the Process Development (PD) function for Caribou’s gene-edited cell therapies.  The Senior Manager/Associate Director of PD is responsible for development and oversight of the manufacturing process for multiple gene-edited cell therapeutic products and will manage a team of PD Engineers and Associates. In addition, this role oversees the Manufacturing Operations function which includes managing technical transfer of manufacturing processes to Contract Manufacturing Organizations (CMOs). This role oversees GMP manufacturing of clinical trial materials including batch record review, and manufacturing oversight and impact assessments on Deviations, Investigations, CAPAs, and Change Controls related to the manufacturing process. This role reports to the Vice President of Technical Operations.

 

Principal Duties and Responsibilities:

  • Lead all Process Development efforts for preclinical and clinical cell therapy programs
  • Manage and grow 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 principles 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
  • Participate in cross-functional teams, working in a highly matrixed team environment to advance preclinical programs

 

Candidates must possess:

  • PhD. or Master’s degree in Cell Biology, Immunology, Biochemistry, Bioengineering, Molecular Biology or a related field, or commensurate relevant work experience
  • Minimum of 7 years of process development experience working in pharma or biotech
  • Experience managing an internal cell therapy PD 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%

 

Pluses:

 

  • Direct hands-on experience manufacturing CAR-T cells
  • Experience with gene engineering techniques
  • Experience with viral transduction systems
  • Experience with iPSC development
  • Experience with late stage clinical or commercial manufacturing
  • 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 offers a comprehensive compensation package, as well as generous paid time off in addition to Company-observed holidays. The Company provides medical, dental, and vision insurance, along with a 401(k) retirement savings plan which includes matching employer contributions.

 

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

 

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.

 

Direct applicants only. No agencies please.

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  • Location
    Berkeley, California
  • Department
    165 - Process Development
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor