Director, Analytical Development - CMC
- Full-Time
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.
Verve is seeking a Director, Analytical Development to provide leadership within the Analytical Development – CMC function. The individual will lead a team of scientists and associates to develop and implement new and improved analytical methods and assays for the characterization of raw materials, RNA drug substances, and LNP drug products for candidates in various development stages. Additionally, the team supports testing non-GMP samples to support development studies such as comparability assessments, process development, stability, product and process characterization. The position will be part of a Technical Operations team that partners closely with Quality Control, Quality Assurance, Process Development and Analytical Research & Development.
Job Responsibilities- Lead a team of scientists and research associates working on mRNA, gRNA and LNP assays focused on biophysical methodologies.
- Provide technical expertise for the structural characterization of gRNAs, mRNAs and lipid nanoparticle (LNP) complexes.
- Partner across the Analytical Development team and cross-functionally to lead, plan, and execute complex characterization studies; serve as the analytical lead in cross-functional interactions.
- Develop and implement methods intended for a variety of purposes, including release and stability testing, product characterization, and high throughput analysis.
- Serve as analytical lead for CMC project teams.
- Oversee troubleshooting, tech transfer, and phase-appropriate GMP validation of analytical methods at the Verve internal Quality Control lab and at contract testing labs in collaboration with Verve Quality Control.
- Author and review technical reports and regulatory submissions.
- Provide guidance and support to team members, promoting their professional growth and development.
- Effectively manage multiple projects to ensure timely delivery.
- Foster a culture of lab safety, data integrity, collaboration, innovation, continuous improvement and accountability within the team.
- Other duties as assigned.
- BS in a life sciences field, MS or PhD in analytical chemistry (preferred) with 10+ years of analytical development experience.
- Prior laboratory operations and management experience leading a team of scientists and associates for analytical development in a clinical stage biotech environment.
- Prior experience must include performing analytical assays to support the development of lead molecules, troubleshooting and optimizing analytical assays for GMP use per ICH guidelines.
- Experience with planning and executing product and process development studies such as forced degradation, comparability assessments, stability, etc.
- Demonstrated competency in operating HPLC/UPLC/LC-MS instrumentation.
- Hands-on experience analyzing DNA/RNA by IP-RP, IEX, LC-fluor and multi-modal LC techniques required.
- Direct experience analyzing LNPs and RNA by biophysical techniques such as DSC, CGE, UV thermal analysis, DLS, MALS, Ribogreen, etc.
- Conceptual understanding of solid phase oligonucleotide synthesis and purification strategies.
- Knowledge/hands-on experience in oligonucleotide lipid nanoparticle delivery, production and purification of short and large oligonucleotides, protein engineering and process development are a plus, but not required.
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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