• Act as main point of contact for CDMOs during late-stage production of regulatory starting materials • Champion deliberate, mindful execution of scale up and technology transfers • Work within a cross-functional team on assigned projects to define or refine a phase-appropriate control strategy, including the identification and justification of critical material attributes, critical equipment attributes, and critical process parameters • Use engineering principles and risk management methodologies to evaluate experimental data or manufacturing performance and identify opportunities for process optimization and improvement throughout the product lifecycle • Troubleshoot production issues and work in cross functional teams to implement effective and persistent corrective/preventative measures • Author, review, and/or edit key CMC and quality deliverables, including (but not limited to): campaign reports, PPQ protocols and reports, tech transfer reports, master batch records, deviation reports, control strategy summaries • Support Reg CMC by reviewing or authoring drug substance sections of various filings, or by supporting Nuvalent responses to health authority questions • Communicate effectively with technical and non-technical stakeholders as required to keep teams abreast of progress, deliveries, timelines, or potential risks thereto • Commit to cGMP principles and Nuvalent’s quality system, and maintain the utmost concern for the health of our patients