Senior Research Associate/Principal Associate, Cell Therapy Process Development
We are seeking a Senior Research Associate/Principal Associate, Purification and Cell Therapy Process Development to join an exciting, fast-growing and well financed company to develop novel gene editing therapies for serious diseases. This position will be a laboratory-based role in the development of late stage CAR T cell manufacturing process for Phase III readiness and beyond. The ideal candidate will be a process engineer with experience in both late stage process development, BLA-enabling study designs, and knowledge of T- cell biology, Immunology, stem cell and gene editing cell therapies. The position requires enthusiasm, passion, attention to detail, and a desire to create important new medicines for patients.
The successful candidates will have significant experience in designing and performing experiments in cancer biology or immunology; including cell culture and genetic manipulation of immune cells, and multi-color flow cytometry experience.
- Participate in development activities in the CAR T cell manufacturing process
- Execute and analyze DOE experiments to help establish unit operation robustness and improve manufacturing technologies towards phase III readiness
- Support multiple preclinical and clinical projects by performing in-process assays including multi-color flow cytometry, media analysis, cell counts and viability, to support late stage CAR T process development
- Support purification related evaluation and review on starting materials (Cas9, gRNA, AAV) provided by CROs, and execute purification activities as needed
- Maintain timely, clear, and complete experiment records; draft protocols, SOPs, and development reports
- Analyze and present experimental data to key stakeholders;
- Organize and maintain group records such as inventories, batch records, PD reports, sampling plans, investigation reports, OQ/PQ plans, and reports to facilitate tech transfer, manufacturing, and regulatory submissions.
- Maintain laboratory equipment, facilities, consumables, materials and inventories
- Assist in building infrastructure to streamline day-to-day data entry and centralize institution knowledge sharing
- Work closely with process development, analytical development, GMP operation and clinical supply chain groups within tech ops department
- Bachelor’s in chemical engineering, biology, chemistry, or related disciplines with 3+ industrial experiences
- Process development experiences with biotherapeutics production on upstream or downstream
- Knowledge of GMP/GLP, process development, process characterization and validation
- Strong interest in CAR T cell therapy process development; highly adaptable, a self-motivated quick learner with significant attention to detail and tracking record of keeping on tight timelines
- Ability to manage own time and workflow and support multiple projects in parallel
- Proven interpersonal and organizational skills are critical.
- Passion in building automated infrastructure/database to streamline day-to-day data entry and institution knowledge maintenance
- Proficient in Excel, PowerPoint, SharePoint, Infopath and familiar with DOE (Design of Experiment) using tools such as JMP or equivalent
- Opportunities will be provided to acquire new skills in an innovative and fast-paced environment.
- Knowledge with T cell biology, mammalian cell culture, AAV production, FACS, qPCR and CAS9/gRNA gene editing technologies
- Familiarity to work with cell therapy process development instruments including Xuri Bioreactor, Beckman Coulter FCAS Flow Cytometer and the Miltengyi Prodigy
- Experience in automated purification and analytical systems such as AKTA and HPLC
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission. The sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
If interested and qualified, please include Requisition # 2018-407 in the subject line when emailing resume to: firstname.lastname@example.org.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.