Nuvalent, Inc. · 12 hours ago
Associate Director, Chemical Development
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$175K/yr - $205K/yr
7+ years expNuvalent is an early-stage company focused on creating selective medicines for cancer patients. The Associate Director, Chemical Development will leverage manufacturing experience and chemical engineering principles to support process design, scale-up, and production of small molecule drug substances.
BiotechnologyLife ScienceTherapeutics
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
Qualification
Required
Advanced degree in Chemical Engineering with at least 7 years of experience in small molecule drug substance production
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
Preferred
Applicants with a bachelor's degree and more extensive experience are encouraged to apply
Benefits
Medical, dental, and vision insurance
401(k) retirement savings plan
Generous paid time off (including a summer and winter company shutdown)
Company
Nuvalent, Inc.
Nuvalent is creating precisely targeted therapies for patients with cancer designed to overcome the limitations of existing therapies for clinically proven kinase targets.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.82BKey Investors
Bain Capital Life SciencesDeerfield
2025-11-18Post Ipo Secondary· $500M
2024-09-16Post Ipo Equity· $575M
2023-10-16Post Ipo Equity· $300M
Leadership Team
James Porter
CEO
Alexandra Balcom
Chief Financial Officer
Recent News
2026-02-05
Company data provided by crunchbase