Executive Director Analytical Development
Reporting to the Senior Vice President of Technical Operations, the Executive Director of Analytical Development will be responsible for strategic planning and execution of analytical development activities for all clinical programs. In this leadership role, the successful candidate will direct and expand the existing analytical development team to develop lot release and characterization assays and tech transfer them to our clinical manufacturing sites. The position requires enthusiasm, passion, attention to detail and a desire to develop cutting edge technology for CRISPR-based gene-edited living medicines for patients. This position will require up to 20% travel to assist in tech transfer and manufacturing-related activities across the GMP manufacturing sites.
- Provide strategic direction and management of the Analytical Development group for the development and tech transfer of assays for all CRISPR products in development and clinical trials
- Provide a strategy for analytics of CRISPR drug substance and drug product for clinical products through commercial launch
- Direct the Analytical Development team for:
- Development and validation of analytical methods at contract manufacturers and laboratories for release and stability testing for drug substance and drug product
- Phase appropriate development and execution of studies both internally and with contract labs for CRISPR clinical products
- Selection of third party testing laboratories, and oversight of phase-appropriate method validation, method transfer, testing plans, and data verification
- Experimental designs and critical review of validation protocols and reports; review and interpretation of analytical data for drug substance and drug product, and effective communication of results.
- Execution of formal and informal stability studies, statistical analysis of data and action plans based on stability outcomes
- Establishment of clinical phase-appropriate specifications and control strategies for critical raw materials, intermediates, drug substance, excipients and drug product
- Characterization of critical raw materials, drug substance and drug product for early through late-stage development programs
- Assessment and approval of method change controls, investigation of OOS and OOT test results, and follow-up of corrective actions
- Implementation of state of the art strategies to elucidate critical quality attributes (CQA’s) of drug substance and drug product throughout the product life cycle
- Representation of the Analytical Development function on cross-functional teams
- Author and review regulatory documents (IND, IMPD, BLA…) and support regulatory submissions and responses.
- Collaborate effectively with the Project Management, Quality, and Regulatory groups to meet program goals.
- Serve as an integral member of the Technical Operations Leadership Team, ensuring cross-functional alignment of analytical program deliverables with overall program strategy.
- Represent the Technical Operations analytical organization in meetings with FDA, EMA and related regulatory authorities.
- Ph.D. in Biological Sciences or related fields
- 15+ years’ experience working within a cGMP analytical development and/or QC role in the biologics/pharmaceutical industry
- Leadership role in the analytical development area for at least 10 years with cell and gene therapy experience highly beneficial
- Experience with a breadth of biological analytics applicable to cell therapies including NGS, qPCR, ddPCR, viral vectors, and flow cytometry
- Experience with analytics and guidance for cell and gene therapy products is highly beneficial
- Experience in analytical development for clinical and commercial products with extensive participation in analytical development leading to at least 2 BLAs
- Must be willing to travel domestically and internationally up to 20%
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities while maintaining attention to detail
- Clear and succinct verbal and written communication skills
- Strong analytical, problem solving and critical thinking skills
- Ability to influence others and work independently and in a team environment
- Experience working closely with Manufacturing, QC, Project Management, functional team leaders, clinical teams and contract manufacturing partners
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
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.