Process Development Engineer

Our fun and collaborative Process Development Team is seeking an innovative and highly motivated Scientist/Engineer 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 clinical 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 of Deviations, Investigations, CAPAs, and Change Controls related to the manufacturing process.

Responsibilities include:

Independently design and implement Process Development projects for preclinical and clinical cell therapy programs
Optimize cell culture, cell differentiation, 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 genome-edited cell therapeutics including CAR-T and CAR-NK 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, Developmental Biology, 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 (cGMP)
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:

Extensive experience managing cell-based process development and technology transfer
Direct hands-on experience manufacturing NK 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 compensation and benefits include:

Comprehensive compensation package, which includes stock options and an employee stock purchase program for all employees
Generous paid vacation time, in addition to company-observed holidays and floating holidays
Excellent medical, dental, and vision insurance
401(k) retirement savings plan, which includes matching employer contributions
Tuition reimbursement program
Caribou is an equal opportunity employer and does not discriminate based on 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 United States 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 requires employees to be fully vaccinated, including a booster shot, against COVID-19 unless they have an approved medical or religious accommodation. Proof of such vaccination will be required as part of the hiring process.

For more information about Caribou, visit www.cariboubio.com and follow the company @CaribouBio.

To apply for this job please visit boards.greenhouse.io.

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