1 день назад
Associate Director, Material Science (Small Molecule Drug Development)
169 222 - 253 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Material Science (Small Molecule Drug Development): Leading materials science strategy for small molecule drug substance and drug product programs from IND through NDA and commercialization, with an accent on solid-state form selection, particle engineering, material characterization, and control strategies. Focus on managing material-related risks, supporting regulatory CMC submissions, and leading technology transfer, scale-up, validation, and commercial manufacturing activities.
Location: Remote within the United States
Salary: $169,222–$253,000 per year, plus incentive opportunity
Company
develops pharmaceutical products and supports drug development and commercialization programs.
What you will do
- Lead materials science strategy for small molecule drug substance and drug product programs from IND-enabling development through NDA, commercialization, and lifecycle management.
- Direct solid-state form selection, particle engineering, excipient compatibility, material characterization, and definition of critical material attributes.
- Establish material control strategies and assess risks related to polymorphism, hygroscopicity, particle size, manufacturability, and product stability.
- Support formulation development, scale-up, engineering and PPQ batches, validation, and technology transfer to internal and external manufacturing sites.
- Author, review, and approve IND and NDA/MAA CMC sections and support health authority interactions.
- Represent materials science on cross-functional CMC and project teams, providing data-driven recommendations and scientific oversight.
Requirements
- PhD in Materials Science, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field, or an MS with substantial relevant industry experience.
- Typically 8–12+ years of pharmaceutical or biotech drug development experience focused on small molecule programs.
- Experience with solid-state chemistry, polymorphism, salt selection, particle engineering, and material characterization techniques including XRPD, DSC, TGA, DVS, spectroscopy, microscopy, and particle size analysis.
- Experience supporting IND and NDA submissions, formulation development, scale-up, GMP manufacturing, technology transfer, and commercial manufacturing.
- Knowledge of QbD, risk assessments, lifecycle management, regulatory technical writing, and oral solid dosage forms.
- Strong communication, strategic thinking, problem-solving, decision-making, and cross-functional leadership skills.
Culture & Benefits
- Remote work arrangement for the United States-based role.
- Medical, dental, vision, prescription drug, life, AD&D, short-term disability, and long-term disability 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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