Associate Director, Chemical Development
Scorpion Therapeutics, Cambridge, Massachusetts, us, 02140
Role Summary
Associate Director, Chemical Development will apply direct manufacturing experience and chemical engineering tools and principles to support process design, scale-up, technology transfer, control strategy verification, and production of small molecule drug substances and related compounds. The role will provide actionable, technically sound recommendations to strengthen manufacturing robustness and ensure continuity of supply throughout the lifecycle of Nuvalent’s products. The incumbent will work 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. 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 Skills
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 Qualifications
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
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Associate Director, Chemical Development will apply direct manufacturing experience and chemical engineering tools and principles to support process design, scale-up, technology transfer, control strategy verification, and production of small molecule drug substances and related compounds. The role will provide actionable, technically sound recommendations to strengthen manufacturing robustness and ensure continuity of supply throughout the lifecycle of Nuvalent’s products. The incumbent will work 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. 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 Skills
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 Qualifications
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
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