9 часов назад
Associate Director, Analytical (Structural Characterization) (Pharmaceutical Structural Characterization)
169 222 - 253 000$
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Описание вакансии
Текст:
TL;DR
Associate Director, Analytical (Structural Characterization) (Pharmaceutical Structural Characterization): Leading small molecule structural characterization strategies across discovery, development, regulatory submissions, and commercialization with an accent on impurity profiling, degradation analysis, and solid-state characterization. Focus on solving complex analytical and CMC issues, validating fit-for-purpose methods, and guiding cross-functional development and regulatory decisions.
Location: Princeton, New Jersey, United States
Salary: $169,222–$253,000 annually, plus incentive opportunity.
Company
develops and commercializes pharmaceutical products and supports research, development, and patient-focused healthcare solutions.
What you will do
- Lead scientific strategy and execution for small molecule structural characterization across discovery, development, commercialization, and lifecycle management.
- Provide expertise in molecular identity, impurity profiling, degradation pathways, and solid-state properties.
- Oversee analytical method development, qualification, and validation across spectroscopic, chromatographic, impurity, degradation, and solid-state platforms.
- Support process development, scale-up, comparability, formulation, API solid-form control, specifications, control strategies, and stability programs.
- Author, review, and approve analytical sections of IND, NDA, and post-approval regulatory submissions and responses.
- Lead cross-functional projects and oversee work performed by CROs, CDMOs, and analytical vendors.
Requirements
- PhD in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a related discipline, or an MS with significant and progressive industry experience.
- 8–10+ years of experience in small molecule analytical development within the pharmaceutical or biotech industry.
- Expertise in structural elucidation, impurity characterization, solid-state chemistry, and analytical control strategies.
- Experience supporting CMC development and IND/NDA regulatory submissions.
- Experience working in GxP-regulated environments and interpreting complex analytical data.
- Ability to work in Princeton, New Jersey, United States.
Nice to have
- Prior people leadership or strong matrix leadership experience.
- Experience establishing scalable analytical processes in a growing organization.
Culture & Benefits
- Fast-paced, resource-conscious environment with opportunities to lead change and continuous improvement.
- Cross-functional collaboration with Process Chemistry, Formulation, Manufacturing, Quality, and Regulatory Affairs.
- Medical, dental, vision, prescription drug, life, and disability insurance coverage.
- Tuition reimbursement, student loan assistance, and a generous 401(k) match.
- Flexible time off, paid holidays, and paid leave programs.
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