Company Overview

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.

Position Summary

Reporting to the Senior Director of Analytical Development, the Director of Analytical Development will help in the planning and execution of all LNP analytical development activities for our in vivo clinical programs. In this leadership role, the successful candidate will direct a group of Analytical Development scientists and Research Associates, participate as analytical lead in matrix CMC Teams, interact with CMOs and CTOs and support regulatory interactions and filings. The position requires enthusiasm, passion, attention to detail and a desire to develop cutting-edge technology for CRISPR-based gene-edited medicines for patients. This position may require up to 20% travel to assist in tech transfer and manufacturing-related activities across the GMP manufacturing sites.

Responsibilities 

• Lead and train personnel to develop, transfer, qualify, and validate potency assays for CRISPR-products and critical components. 

• Explore/bring in new technology and techniques to strengthen and streamline the analyses of LNP drug product and its critical components (sgRNAs, mRNAs, lipids).  

• Provide leadership and career mentorship to scientific team members as team expands over time. Contribute towards the short- and long-term strategical planning (< 12 m, > 12 m) and responsible for tactical implementation of assigned projects and delivering results to achieve departmental and company goals.   

• Collaborate with external CRO/CDMOs to lead the development, qualification, transfer, and validation of analytical methods—including release, in-process, stability-indicating, and characterization assays—for critical components and drug products in CRISPR-based programs. Responsibilities include managing and prioritizing these activities, as well as providing thorough review and approval of analytical methods, SOPs, protocols, reports, raw data, and reference material qualifications. 

• Represent Analytical Development (part of Technical Operations Department) in internal and external meetings and collaborate effectively with multifunctional stakeholders. 

Minimum Qualifications 

• Ph.D. with 10+ years (or 12-15+ years with BS) of extensive experience in managing analytical development groups and a good understanding of cGMP and GLP requirements. 

• Deep knowledge of cell-based potency assays as well as a strong understanding of orthogonal assays are required.  

• Extensive knowledge of common analytical techniques is required to allow guiding the analytical team: HPLC (IPRP, SEC, IEX), LC-MS, capillary gel electrophoresis, qPCR, ELISA, western blotting, DLS, MALS, mass spectrometry.  

• Prior experience in leading phase-appropriate analytical method development, optimization, and qualification for lot release, stability, and characterization of products using lipid nanoparticle (LNP) formulations is needed. Establish, guide, and monitor implementation of these methodology and corresponding specifications of various products.  Knowledge of statistics in general and working experience with JMP software would be a plus. Direct experience in product life cycle management from research/preclinical to commercial stages would be a plus. 

• A strong understanding of GMP, compendial (USP, Eur. Ph., and JP), and regulatory (e.g., ICH, FDA, EMA) requirements and expectations that are aligned with the product's development stage is essential for success in this role. Prior experience in authoring regulatory submissions (IND, CTA, BLA) and leading responses to regulatory inquiries is highly valued. 

• Exceptional communication, organizational, and problem-solving skills 

Preferred Qualifications 

• Experience with analysis of RNAs, lipids, and lipid nanoparticles (LNPs) is highly desirable.