Назад
Company hidden
1 день назад

Senior Scientist (Drug Product Analytical Development)

162 000 - 186 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
/
TL;DR
Senior Scientist (Drug Product Analytical Development): Developing and managing analytical methods, validation, stability programs, and control strategies for drug product formulations with an accent on amorphous solid dispersions, lipid-based systems, and regulatory submissions. Focus on overseeing CDMO/CRO testing, analyzing stability trends, supporting PPQ and commercialization, and authoring IND/IMPD/NDA documentation.

Location: Onsite at Nurix headquarters in Brisbane, California, United States. Travel up to 5% may be required.

Salary: $162,000–$186,000 per year.

Company

hirify.global is a clinical-stage biopharmaceutical company developing targeted protein degradation medicines for oncology and inflammatory diseases.

What you will do

  • Lead analytical method development, validation, and lifecycle management for drug product formulations, including amorphous solid dispersions and lipid-based systems.
  • Design and oversee development, registration-batch, and commercial stability programs, including protocols, trend analysis, retest periods, and shelf-life evaluations.
  • Provide technical oversight of analytical development, validation, and QC testing performed by CDMOs and contract testing laboratories.
  • Support PPQ, commercialization, commercial QC, tech transfer, and analytical control strategy activities.
  • Author and review analytical development reports, specifications, validation and stability documents, certificates of analysis, and regulatory submission sections.
  • Contribute to investigations, root-cause analyses, CAPAs, data integrity, inspection readiness, and responses to health authority requests.

Requirements

  • Advanced degree in Chemistry, Pharmaceutics, or a related discipline.
  • BS/MS with 14+ years or PhD with 8+ years of industrial CMC experience.
  • Strong experience in drug product analytical development and validation, including chromatographic and dissolution methods.
  • Experience with amorphous solid dispersions and/or lipid-based formulations, CDMO oversight, and contract testing laboratories.
  • Experience supporting IND, IMPD, NDA, and global regulatory filings.
  • Fluency with ICH guidelines, cGMP requirements, pharmacopeial chapters, technical writing, and cross-functional collaboration.

Culture & Benefits

  • Work as part of multidisciplinary teams spanning Chemical Development, Pharmaceutical Development, Regulatory, Quality, Preclinical, Supply Chain, Medicinal Chemistry, and DMPK.
  • Support oncology and inflammation and immunology development programs in a clinical-stage biopharmaceutical environment.
  • Maintain analytical documentation and data for traceability, data integrity, and inspection readiness.
  • Follow cGMP requirements and internal SOPs while managing multiple priorities in a fast-paced setting.

Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →