- 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
- 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
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Vice President, Analytical Development - Boston, MA, United States - Verve Therapeutics, Inc.
Description
Job Description
Job Description
The Company
Verve Therapeutics is a biotechnology company created with a singular focus: to protect the world from heart disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, the company aims to develop transformative, once-and-done therapies for coronary heart disease. Verve's gene editing medicines are designed to safely edit the genome of adults and mimic naturally occurring gene variants to permanently lower LDL cholesterol and triglyceride levels. The company is advancing a pipeline of precision genetic medicines, led by VERVE-101, which is being developed initially for heterozygous familial hypercholesterolemia, a potentially fatal genetic heart disease. 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 PositionVerve 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 ResponsibilitiesEEO 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 AgenciesVerve 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.
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