Associate Director, Analytical Development - CMC

The Position

Verve is seeking an Associate Director, Analytical Development to provide leadership within the Analytical Development – CMC function. The individual will lead a team to develop and implement new analytical methods, as well as optimize and improve the current methods, for the characterization of raw materials, RNA drug substances, and LNP drug products in the programs at 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 HPLC based method development and other 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.
• 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

• 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.