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13 дней назад

Scientist, Analytical Development, Small Molecule

127 000 - 165 500$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
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
Scientist, Analytical Development, Small Molecule (Pharmaceutical Development): Developing and validating analytical methods for small molecule inhalation, solid oral, and liquid drug products across early development through commercialization with an accent on GMP compliance, data integrity, and regulatory documentation. Focus on characterizing drug substances and products, leading pre-formulation and stability studies, detecting nitrosamine impurities, and solving complex analytical challenges for CMC and IND/NDA submissions.

Location: Bridgewater, New Jersey; full-time, in-person presence required

Salary: $127,000–$165,500 annual

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

  • Perform routine analytical testing for inhalation combination products, tablet formulations, and oral solutions from early development through Phase III and commercialization.
  • Develop and validate analytical methods using HPLC, UPLC, GC, XRPD, Raman, PSD, FTIR, dissolution, and related techniques.
  • Lead pre-formulation and stability studies to assess product quality and shelf life.
  • Analyze complex data, identify method or product-quality issues, and develop scientifically sound solutions.
  • Prepare protocols, development and validation reports, regulatory submissions, and analytical documentation for IND and NDA filings.
  • Collaborate with formulation, process development, and regulatory teams on CMC activities.

Requirements

  • Bachelor’s degree and at least five years of chemistry experience.
  • Hands-on analytical laboratory experience with inhalation, solid oral, and liquid dosage forms.
  • Knowledge of cGxP, GMP, CMC, ICH, and USP/EP/JP requirements.
  • Experience conducting risk assessments and developing methods for detecting and controlling nitrosamine impurities.
  • Strong attention to detail, advanced Microsoft Office skills, and the ability to work effectively in a dynamic, culturally diverse environment.
  • Must work full-time in person at the Bridgewater, NJ office.

Nice to have

  • Experience with inhalation and combination products.

Culture & Benefits

  • Medical, dental, vision, and mental health support.
  • Paid time off, family-forming benefits, caregiver support, and flexible schedules with purposeful in-person collaboration.
  • 401(k) with company match, equity awards, ESPP, and company-paid life and disability insurance.
  • Learning programs, mentorship, employee resource groups, and service opportunities.
  • Minimal travel expected.

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