Director – Cell and Molecular Biology

The Position

Verve is seeking a Director of Cell and Molecular Biology within its Analytical Development-CMC team to support analytical method development and testing of mRNA and gRNA oligonucleotide drug substance and drug product across all stages of development. This individual will be leading a cross-disciplined team to design, develop and qualify phase appropriate analytical methods (focusing on in vitro cell based potency assay) to support Verve’s growing gene editing pipeline. 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

• Oversee a vibrant team working on mRNA and guide RNA cell-based potency assays using varied delivery methods (e.g., Lipid nanoparticles).
• Extensive experience in molecular biology, mammalian cell biology techniques and assays.
• Manage the development, qualification and transfer methods to the quality control group or external testing labs.
• 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.

Qualifications

• Advanced degree (MS or PhD) in Molecular/Cell Biology, Genetics, Virology, Bioengineering, or related life sciences field with strong scientific background and 10+ years’ relevant experience.
• Proven experience in oligonucleotide analytical qPCR, RT-qPCR, cell-based assays and/or NGS method development, quality control processes and hand-on experience with state-of-the-art analytical instruments.
• Prior laboratory operations and management experience leading a team of scientists and associates for analytical development in a clinical stage biotech environment.
• Prior experience 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.
• 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.