Senior Engineer/Associate Principal Engineer, LNP Process Development

2 months ago

Boston, United States Verve Therapeutics, Inc. Full time
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

As a Senior Engineer/Associate Principal Engineer in the LNP Process Development team, you will have a highly visible and integral role towards the process development, scale-up, and manufacturing of Verve's novel gene editing therapies. The ideal candidate will have experience with lipid nanoparticle process development, tech transfer, and GMP manufacturing support. In this highly collaborative and cross-functional role, you will help refine Verve's process control and improve process understanding for multiple programs at various stages of clinical development. While you will initially serve as an individual contributor, you will mentor and train team members and cross-functional partners.

We are considering local candidates at this time.

Job Responsibilities
  • Lead, design, and execute studies in the lab independently and collaboratively with other colleagues.
  • Provide readouts and recommendations to cross-functional internal and external teams.
  • Contribute to establishing a science-based understanding of LNP formulation and drug product filling to inform improvements to process and product quality.
  • Design and contribute to scale up LNP process development experiments focused on maintaining product quality and reducing cost of goods.
  • Contribute to strategic planning of GMP manufacturing campaigns, with emphasis on establishing internal readiness, coordinating with external vendors, and managing timelines and deliverables.
  • Contribute to refining the technical requirements for tech transfer and process implementation at a GMP manufacturing facility, including equipment specification, draft procedures, and recommended operating parameters/ranges.
  • Write and provide technical review of GMP documents including tech transfer reports, SOPs, manufacturing batch records, campaign summary reports, etc.
  • Write protocols and technical reports to support clinical development of RNA-based gene editing therapeutics.
  • Other duties as assigned.
Qualifications
  • Senior Engineer
    • Bachelor's degree in chemical/ biomedical engineering, chemistry, or biological sciences with 5+ years of relevant industry experience
    • Master's degree in chemical/ biomedical engineering, chemistry, or biological sciences with 2+ years of relevant industry experience
    • Ph.D. in chemical/ biomedical engineering, chemistry, or biological sciences
  • Associate Principal Engineer
    • Bachelor's degree in chemical/ biomedical engineering, chemistry, or biological sciences with 8+ years of relevant industry experience
    • Master's degree in chemical/ biomedical engineering, chemistry, or biological sciences with 4+ years of relevant industry experience
    • Ph.D. in chemical/ biomedical engineering, chemistry, or biological sciences with 3+ years of relevant industry experience
  • Extensive knowledge of drug substance and/or drug product scale-up and manufacturing of LNPs (preferred), biologics, or nucleic acids, with a focus on mixing and TFF process scale-up.
  • Extensive experience with design and selection of equipment and consumables that will be used in GMP settings.
  • Knowledge of practices and equipment to run manufacturing processes in a GMP environment, including bioreactors, fermenters, mixers, TFF, sterile filtration, single-use technology, and sterile/aseptic processing.
  • Highly collaborative and detail-oriented approach to facilitating the work of cross-functional teams and external vendors.
  • Attention to detail, critical analysis of data/reports, and troubleshooting abilities.
  • Proven ability to achieve results, keep projects on timeline, and find solutions to ensure that project deliverables are met.
  • Ability to mentor and cross-train more junior scientists and engineers in performing lab-based activities.


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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