Vice President, Analytical Development

The Position

Verve is seeking a Vice President, Analytical Development to lead the CMC Analytical team reporting to the Chief Technical Operations Officer. The role will be working cross-functionally to develop and implement new methods and assays for the characterization of raw materials, RNA drug substances, and LNP drug products. This individual will act as a scientific thought leader for the CMC and company-wide analytical strategy at Verve.

Job Responsibilities

• Lead and grow a team of analytical scientists and research associates responsible for:

• Developing and optimizing analytical assays across different stages of drug development for gRNA, mRNA, lipids, and LNPs

• Testing non-GMP samples to support development studies such as comparability assessments, process development, stability, product and process characterization, etc.

• Collaborating closely with the R&D and Quality Control teams to transfer and qualify methods at CDMOs, CROs, and Verve's internal QC lab

• Enhancing our product and process understanding by characterizing impurities, defining CQAs, process troubleshooting, supporting process control strategies

• Improve lab management and operations including lab safety, budget, quality systems, data reporting/management, productivity initiatives, etc.

• Write and review regulatory filings and briefing books; represent the company in regulatory interactions

• Promote a culture of continuous improvement and collaboration

Qualifications

• Demonstrated history of effective leadership, including hiring and developing top talent

• Experience with method development, qualification, and validation for clinical and commercial products

• Experience in characterization of advanced therapies, ideally gene editing, RNA, and/or LNP products

• Experience with international regulatory interactions: writing filings, responding to information requests, scientific advice meetings, etc.

• Excellent written and verbal communication skills; strong communicator and influencer within all levels of the organization, including executive leadership

• BS in sciences, analytical chemistry, biochemistry, pharmacy, or related area, advanced degree preferred with 15+ years of progressive leadership experience

The targeted salary range for this position is $288,000 - $360,000 per year. Verve is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Verve's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.