Process Development Senior Scientist
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 five-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 Senior Scientist to lead our newly created Process Development group in Berkeley. The ideal candidate will establish, direct, and manage 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 manage the technology transfer to a CMO/CRO.
Responsibilities will include:
- Establish a process development program designed to optimize manufacture and production of the company’s products for preclinical programs
- Develop cell separation, cell enrichment, gene editing, formulation and related processes for scale-up
- Use engineering principles to leverage bench and pilot scale models for process performance characterization
- Participate in the identification and selection of CMO/CRO partners
- 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
- Oversee development of 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 pre-clinical programs
Candidate must possess:
- PhD degree or equivalent experience in Biochemistry, Bioengineering, Molecular Biology or a related field
- Minimum of 5 years of experience in process development working in research or manufacturing operations in pharma or biotech
- Extensive experience managing cell-based process development and technology transfer
- Ability to manage CMO/CRO interactions 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 transferring gene engineering based cell therapies toward GMP
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.