Process Development Scientist/Engineer

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

Caribou Biosciences, Inc. is a leading company in CRISPR genome engineering located in Berkeley, CA. Caribou's tools and technologies provide transformative capabilities to therapeutic development and the company is advancing an internal pipeline of gene-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 and background. Every person on the Caribou team contributes to problem solving and innovation. The Company’s vision is to advance agile gene editing innovations for the benefit of our communities.

 

We are seeking a Process Development Scientist/Engineer to contribute to our Process Development group in Berkeley. The ideal candidate will participate in the Process Development efforts and interact closely with functional group leaders, scientists and research associates to transfer the technology from discovery through tech transfer and GMP manufacturing. This hands-on role will involve design and execution of the experiments for process development, optimization, scale-up, and tech transfer, and will help manage the technology transfer to a CMO/CRO.

 

Responsibilities will include:

 

  • Develop cell enrichment, cell expansion, electroporation, final formulation and related processes for scale-up
  • Use engineering principles to leverage bench and pilot scale models for process performance characterization
  • Transfer technologies to CMO/CROs and provide training and on-going technical support
  • Design and execute 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 assurance methodologies
  • Generate development reports and prepare SOPs and batch records
  • Develop analytical methods for product evaluation and release
  • Participate in preparation of 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

  

Candidate must possess:

 

  • BS degree in the life sciences or engineering with a minimum of 5 years applicable experience or MS or PhD with a minimum of 2 years applicable experience
  • Minimum of 2 years of experience in pharma or biotech, preferably working in process development and/or manufacturing operations
  • Experience in tissue culture, cell based assays and a working knowledge of cell biology/immunology
  • Experience managing cell-based process development and technology transfer
  • Ability to interact with CMO/CRO teams and maintain professional and productive relationships
  • Experience with statistical design of experiments, advanced data analysis and Quality by Design concepts
  • Excellent verbal and written communication skills
  • Proven ability to work independently, 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

 

Pluses:

 

  • Experience interacting with CMO/CRO partnerships
  • Background in immunology or immune cell engineering
  • Experience developing and tech transferring gene engineering based cell therapies toward GMP-Manufacturing
  • Experience with T cell assay development, particularly multi-color flow cytometry 

 

Caribou Biosciences, Inc. is a dynamic start-up 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.  Sign up to follow our Twitter feed @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 basis 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
    Mid-level