Associate Principal Scientist, mRNA Process Development

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 2021, Verve was selected as a Top Places to Work by The Boston Globe and Best Places to Work by the Boston Business Journal. Verve is headquartered in Cambridge, Massachusetts.

The Position

We are seeking a downstream process development Associate Principal Scientist to join a team focused on developing mRNA manufacturing processes for Verve’s novel CRISPR gene editing therapies. The ideal candidate will have experience with development of chromatographic and filtration manufacturing unit operations for biologics, as well as performing and/or coordinating analytics supporting the development activities. The candidate should be enthusiastic about mRNA process development and working cross-functionally to achieve Verve’s process development, technology transfer, and clinical manufacturing goals.

Responsibilities

• Develop or optimize nucleic acid downstream manufacturing steps in collaboration with a small team of development scientists and engineers
• Define process parameters and operating ranges for chromatographic, TFF, and sterile filtration unit operations in advance of technology transfer to a manufacturing site
• Author development reports suitable for regulatory filings
• Work cross-functionally to ensure successful implementation of developed processes
• Plan for future stages of mRNA process life cycle including process characterization
• Provide technical support for manufacturing investigations
• Communicate project strategy and experimental results to colleagues and management

Qualifications

• Ph.D. in biology, chemistry, chemical engineering or equivalent with 4+ years of biologics downstream process development experience
• Knowledge of process definition and scale-up of chromatography and filtration for clinical-stage GMP manufacturing
• Proficient in laboratory experiments in downstream unit operations such as column chromatography, tangential flow filtration and sterile filtration
• Proficient with AKTA chromatography systems and associated UNICORN software
• Experience with small scale model qualification, resin reuse studies and/or process characterization preferred
• Experience with DOE and JMP software preferred
• Experience with process associated analytical techniques, such as HPLC, capillary electrophoresis, ELISA, or qPCR preferred
• Established ability to prioritize multiple projects and manage resources to achieve project goals
• Strong attention to detail and ability to troubleshoot and solve technical difficulties

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.