Associate Director, Chemical Development
Nuvalent, Inc.
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $175,000 - $205,000 per year
Job Level
About the role
- 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
Requirements
- 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
Benefits
- medical insurance
- dental insurance
- vision insurance
- 401(k) retirement savings plan
- generous paid time off
- summer and winter company shutdown
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Chemical Engineeringprocess developmentprocess validationstatistical methodsorthogonal design of experimentsrisk management methodologiescritical material attributescritical equipment attributescritical process parameterscGMP principles
Soft Skills
communicationcross-functional teamworktroubleshootingproblem-solvingstakeholder engagementproject managementattention to detailmindful executioncommitment to qualityadaptability