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