Engineer, Process Development

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

Caribou Biosciences, Inc. is a leading clinical-stage CRISPR genome editing 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. Caribou was founded in 2011 by CRISPR pioneers including Nobel Prize winner Jennifer Doudna, PhD, Martin Jinek, PhD, and Rachel Haurwitz, PhD, our President and CEO. The company has developed a novel CRISPR genome editing 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.


Our fun and collaborative Process Development Team is seeking an innovative and highly motivated Scientist to help optimize the platform manufacturing process for Caribou’s gene-edited cell therapies.  Reporting to the VP of Technical Operations, you will have the opportunity to solve the challenges that come with our team’s goal of improving the cell therapy manufacturing process from upstream to downstream.  Partnering with our PD Engineers and Associates, you will evaluate new technologies, reagents and gene-delivery techniques.  Your solutions will quickly be implemented into the manufacturing process, and have a direct impact on trials.  You will have the opportunity to gain experience with multiple aspects of cell therapy clinical development.  This includes the participation in technical transfer of manufacturing processes to Contract Manufacturing Organizations (CMOs). Serving as a cell therapy manufacturing subject matter expert, you will also help manage 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.

 

 

Responsibilities:

  • Independently design and implement Process Development projects for preclinical and clinical cell therapy programs
  • 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 as part of the PD team in full-scale preclinical production of gene-edited CAR-T cells
  • Provide subject matter expertise during technology transfer 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
  • Author development reports, SOPs, change controls, and batch records
  • Contribute to the design of analytical methods for product characterization and release
  • Participate in cross-functional teams, working in a highly matrixed project team environment to advance preclinical programs

 

Qualifications:

  • PhD, MS or BS degree in Cell Biology, Immunology, Biochemistry, Bioengineering, Molecular Biology or a related field, or commensurate relevant work experience
  • Minimum of 5 years of process development experience working in pharma or biotech (cell therapy, gene therapy, antibody or protein production)
  • Cell Biology experience to include: mammalian cell culture and cell-based assays using flow cytometry
  • Intimate understanding of current good manufacturing practices (GMP)
  • Excellent verbal and written communication skills
  • Proven ability 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):

  • Extensive experience managing cell-based process development and technology transfer
  • Direct hands-on experience manufacturing CAR-T cells
  • Experience with gene engineering techniques
  • Experience with viral transduction systems
  • Experience with iPSC development
  • Background in immunology or immune cell engineering or developmental biology
  • Experience with DOE studies, advanced statistical analysis and QBD principles
  • Direct experience managing CMO interactions and building productive relationships

 

Caribou Biosciences, Inc. is a dynamic 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. 

 

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
    Mid-level