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Nuvalent

Nuvalent is a biotechnology research company developing precisely targeted therapies for patients with cancer. To do so, Nuvalent employs professionals across a

Associate Director, Chemical Development

Location

Massachusetts

Posted

134 days ago

Salary

$175K - $205K / year

Seniority

Senior

Postgraduate Degree7 yrs expExperience acceptedEnglish

Job Description

Associate Director, Chemical Development

Nuvalent

• 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

Job 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

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