Associate Director, CMC Project Management at Atrium Therapeutics in San Diego, CA

Job description

Atrium is a biopharmaceutical company pioneering delivery of RNA therapeutics to the heart to transform the standard of care for people living with cardiomyopathies. Our proprietary technology leverages the targeted RNA delivery platform initially designed at Avidity, which combines the tissue selectivity of mAbs and other targeted delivery ligands with the precision of oligonucleotides. This unique combination is designed to allow selective targeting of the underlying genetic drivers of disease that were previously undruggable. Through targeted, non-viral delivery of siRNA to cardiac tissues, our approach has the potential to overcome key limitations of nonspecific viral and nanoparticle-based delivery systems, including challenges related to tissue specificity, immunogenicity, and redosing. Position Summary: The CMC Program Manager is responsible for the planning, coordination, and execution of Chemistry, Manufacturing, and Controls (CMC) activities across Atrium Therapeutics' development portfolio. This individual will serve as the operational lead for CMC program management, driving timelines, budgets, meeting governance, documentation management, and cross-functional coordination to ensure successful program execution from preclinical development through commercialization. Reporting to the Technical Product Lead / Head of CMC Strategy, the CMC Program Manager will work closely with Technical Development, Manufacturing, Quality, Regulatory Affairs, Clinical Supply, and external CDMO partners to align CMC activities with overall program objectives. The role will chair CMC Team meetings, coordinate stage-gate governance, and ensure execution of critical deliverables across the product lifecycle. The ideal candidate possesses a strong understanding of pharmaceutical development and CMC processes, exceptional project management skills, and the ability to drive complex cross-functional initiatives. For qualified candidates, the role offers the opportunity to progressively assume Technical Product Lead responsibilities for early-phase development programs. Job Responsibilities: • Develop, maintain, and communicate integrated CMC development plans across assigned programs. • Drive planning, execution, and monitoring of CMC activities to support preclinical, clinical, and commercial milestones. • Coordinate cross-functional teams to ensure alignment on priorities, deliverables, dependencies, and critical path activities. • Proactively identify program risks, escalate issues, and facilitate development of mitigation strategies. • Provide regular updates on program status, timelines, risks, and budget performance to Technical Development leadership and program teams. • Support portfolio planning, resource management, and long-range development forecasting. Timeline and Budget Management: • Own and maintain CMC project timelines, milestones, and development schedules. • Track critical path activities and ensure timely execution of key deliverables. • Partner with functional leaders to develop, monitor, and manage program budgets. • Track spending against approved budgets and identify potential variances or forecast changes. • Support contract management, purchase order tracking, and budget planning for external development and manufacturing activities. • Generate program metrics and dashboards to support leadership decision-making. Documentation Management: • Coordinate the authoring, review, approval, and archival of CMC technical documentation. • Ensure timely completion of high-quality documentation supporting development, manufacturing, and regulatory activities. • Manage document review workflows and coordinate contributions from cross-functional subject matter experts. • Support preparation and review of: o INDs, IMPDs, CTAs, BLAs, NDAs, and other regulatory submissions o CMC strategies and development plans o Process development reports o Technology transfer documents o Process Characterization and Validation documentation o S