Director, gRNA Process Development

3 weeks ago

Boston, United States Verve Therapeutics, Inc. Full time
Job DescriptionJob DescriptionThe 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

As Director, gRNA Process Development you will have an integral role in Technical Operations contributing to development and clinical-stage manufacturing of Verve's novel gene editing products. The ideal candidate will have experience with oligonucleotide process development, oligonucleotide synthesis, tech transfer, scale-up, and GMP manufacturing support. In this highly collaborative role, you will lead a gRNA process development team and contribute to advancing Verve's manufacturing strategy for multiple programs at various stages of clinical development.

This is a hybrid role and requires 3-days in our Boston office. We are considering local candidates at this time.

Job Responsibilities
  • Lead a gRNA process development team (including upstream and downstream functions) that is focused on optimization of long oligonucleotide GMP drug substance manufacturing processes.
  • Support, mentor, and develop team members, providing timely and actionable feedback.
  • Contribute to establishing a stage-appropriate process control strategy to support gRNA manufacture through clinical and commercial development.
  • Refine the technical requirements for upstream and downstream tech transfer and process implementation at a GMP manufacturing facility, including equipment specifications, procedures, and recommended operating parameters/ranges.
  • Support gRNA drug substance manufacturing for Verve's clinical programs.
  • Collaborate with cross-functional teams including Chemistry, Analytical Development, Formulation, Editing, Quality Control, Quality Affairs, and External Manufacturing.
  • Write and/or provide technical review of documentation including process development reports, process descriptions, manufacturing batch records, campaign summary reports, etc.
  • Contribute to global regulatory filings to support clinical development of Verve's products.
  • Other duties as assigned.
Qualifications
  • Ph.D. or equivalent in chemistry, biological sciences, or biomedical/chemical engineering preferred.
  • 10+ years of relevant industry experience in biopharmaceutical process development and tech transfer.
  • Proven people management experience, ensuring high performance and employee development.
  • Technical experience with oligonucleotide synthesis and chemistry.
  • Extensive knowledge of drug substance manufacturing with biologics, viral vectors, or nucleic acids is preferred.
  • Experience as a CMC representative for clinical-stage programs is preferred.
  • Knowledge of practices and equipment to run manufacturing processes in a GMP environment including oligonucleotide synthesis, chromatography, TFF, and sterile/aseptic processing.
  • Familiarity with regulatory submissions and strong technical writing skills are expected.
  • Collaborative and detail-oriented approach to facilitating the work of cross-functional teams.
  • Attention to detail, critical analysis of data/reports, and troubleshooting abilities.
  • Proven ability to achieve results, keep projects on timeline, and find solutions as needed to ensure that project deliverables are met.

Don't check off every box in the requirements listed above? Please consider applying anyway. We want the best candidates for the job, and those candidates don't always meet 100% of the qualifications listed. At Verve, we are dedicated to building diverse and inclusive teams who embody the values we share: grit, spirit, drive, and passion. We look forward to learning more about your unique background.

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.

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