Own CMC oversight across every active asset, ensuring on-time and on-budget delivery of drug substance, drug product, analytics, stability, and regulatory filings.
Select, contract, and manage CDMOs and external partners, holding them to timelines, quality, and cost.
Scope and de-risk the CMC of inherited in-licensing candidates, flagging manufacturing complexity or cost that could affect asset viability.
Lead CMC strategy and execution across clinical-stage therapeutic programs, ensuring regulatory alignment and manufacturing readiness.
Oversee external partnerships with CDMOs, consultants, and regulatory experts to deliver high-quality programs.
Manage CMC activities from due diligence through clinical development, balancing scientific rigor with operational speed.
The company is a partner organization in the biopharmaceutical industry, focusing on clinical-stage therapeutic programs. It operates in a high-growth, mission-driven environment with a culture of innovation and collaboration.
Serve as a trusted CMC advisor to clients, providing strategic guidance across all phases of product development.
Lead and manage CMC development activities for drug substances and drug products, ensuring alignment with program objectives and regulatory requirements.
Oversee CDMO/CMO selection, qualification, contracting, and ongoing management.
We accelerate breakthrough science and delivery of life-enhancing therapies through our expertise, insight, consulting and management skills. We were recently honored with BioSpace's 'Best Places to Work' 2026 award, fostering a positive and engaging work environment with emphasis on culture, career growth, and development.
Lead CMC regulatory activities for IND/CTA development and maintenance to support clinical trials and future MAA/NDA/BLA submissions.
Prepare and review CMC regulatory documents, assess changes, and collaborate cross-functionally to ensure compliance.
Represent regulatory on study teams and maintain knowledge of US and international regulations.
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for cancer patients. The company targets the RAS/MAPK pathway and fosters a collaborative, mission-driven culture.