Director, Analytical Chemistry Extended Characterization

Responsibilities

• Lead a team of scientists working on mRNA, gRNA and LNP assays focused on biophysical extended characterization.
• Partner across the Analytical Development team and cross-functionally with BR&D and SMDD to lead, plan, and execute complex characterization studies; serve as the analytical lead in cross-functional interactions.
• Develop and implement methods intended for product characterization to support late stage and commercialization of gene editing programs.
• Provide technical expertise for the structural characterization of gRNAs, mRNAs and lipid nanoparticle (LNP) complexes.
• Serve as analytical lead for CMC project teams and other VPT teams.
• Oversee troubleshooting, tech transfer, and phase-appropriate GMP validation of analytical methods at the internal Quality Control lab and at contract testing labs in collaboration with Quality team.
• Author and review technical reports and regulatory submissions.
• Provide guidance and support to team members, promoting their professional growth and development.
• Effectively run multiple projects to ensure timely delivery.
• Foster a culture of lab safety, data integrity, collaboration, innovation, continuous improvement and accountability within the team.

Requirements

• PhD in analytical chemistry or bioanalytical chemistry, or a related field with 10+ years of experience in the pharmaceutical industry.
• 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, extended characterization, etc.
• Experience with analytical control strategy implementation, and/or regulatory submissions related to advanced gene therapies.
• Hands-on experience analyzing molecules (DNA/RNA preferred) by IP-RP, IEX, LC-fluor and multi-modal LC techniques.
• Experience developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets.
• Demonstrated success in persuasion, influence, and negotiation.
• Good interpersonal skills and a sustained tendency for collaboration.
• Ability to prioritize multiple activities and handle ambiguity.
• Ability to influence others to promote a positive work environment.
• Demonstrated technical proficiency and ability to create ideas for future work plans.