Vice President, Analytical Development - Verve Therapeutics, Inc.
Boston, MA
About the Job
The Company
Verve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company's initial three programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. In 2023, Verve was named a Top Place to Work by The Boston Globe for the third consecutive year. Verve is headquartered in Boston, Massachusetts.
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.
EEO Statement
Verve Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.
Recruitment & Staffing Agencies
Verve Therapeutics does not accept agency resumes unless contacted directly by internal Verve Talent Acquisition. Please do not forward resumes to Verve employees or any other company location; Verve Therapeutics is not responsible for any fees related to unsolicited resumes.