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1 день назад

Associate Director, Material Science (Small Molecule Drug Development)

169 222 - 253 000$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global 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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