Process Development Research Associate
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, agricultural biotechnology, industrial biotechnology, basic and applied biological research. The six-year-old company has developed a best-in-class CRISPR genome engineering technology platform and has a leading intellectual property position.
We are seeking a Process Development Associate to contribute to our newly created 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 to pre-clinical development. 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 separation, cell enrichment, cell expansion, gene editing, 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:
- Bachelor’s or Master’s degree in Biology or a related field
- 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
- 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 must have the ability and desire to work in a fast-paced environment. For more information, please visit www.cariboubio.com. Caribou is on Twitter. Sign up to follow our Twitter feed @CaribouBio.
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. Caribou promotes a culture in which employees are respected and rewarded for hard work, innovation, personal initiative, and teamwork.
Caribou is an equal opportunity employer and does not unlawfully discriminate on the basis of race, color, religion, citizenship, political activity or affiliation, marital status, age, national origin, ancestry, physical or mental disability, medical condition (as defined under California law), veteran status, sexual orientation, gender identity, gender expression, sex or gender (which includes pregnancy, childbirth, breastfeeding, or related medical conditions), 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.