Associate Director, Chemical Development

Nuvalent • Cambridge, MA

1d

About The Position

With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Research Director, Chemical Development, Associate Director, Chemical Development will apply direct manufacturing experience and chemical engineering tools & principles to support process design, scale up, technology transfer, control strategy verification, and production of small molecule drug substances and related compounds. The incumbent will provide actionable, technically sound recommendations that strengthen manufacturing robustness and ensure continuity of supply throughout the lifecycle of Nuvalent’s products. The incumbent will work directly with the Chemical Development team, and cross-functionally with partners including Quality Assurance, Analytical Sciences and QC, CMC Project Management, Supply Chain, Formulations, and Regulatory Affairs – CMC.

Requirements

• Exceptional interpersonal skills and experience building productive teams and cross functional relationships.
• Ability to think critically with strong attention to detail
• Demonstrated prioritization capabilities to manage multiple projects simultaneously
• Advanced degree in Chemical Engineering with at least 7 years of experience in small molecule drug substance production. Applicants with a bachelor's degree and more extensive experience are encouraged to apply
• Hands-on experience in process development (lab and pilot scales)
• Experience executing process validation studies
• Experience with coordination/management of CDMOs in a virtual paradigm
• Expertise in statistical methods, including orthogonal design of experiments, and associated software for data evaluation and decision making
• Strong understanding of regulatory guidelines as they pertain to small molecule drug substance manufacturing at an innovator company

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director