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12 дней назад

Research Associate II – Nitrosamines (Characterization Team)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
India
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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TL;DR
Research Associate II – Nitrosamines (Characterization Team) (LC-MS/GC-MS): Developing and validating mass spectrometry-based methods to identify and quantify nitrosamine impurities and leachable compounds in pharmaceutical products with an accent on trace-level analysis, chemical extractions, and analytical problem-solving. Focus on designing experiments, interpreting complex mass spectrometric data, developing mitigation strategies, and supporting regulated pharmaceutical research.

Location: Ahmedabad, Gujarat, India

Company

hirify.global develops healthcare and pharmaceutical products focused on improving healthcare delivery and saving and sustaining lives.

What you will do

  • Develop, validate, and transfer quantitative methods for nitrosamine impurities, including small molecules and NDSRIs, at ppm to sub-ppb levels.
  • Design experiments to identify root causes of nitrosamine formation and develop mitigation strategies.
  • Perform chemical extractions of container closure systems and finished drug product solutions for extractables and leachables studies.
  • Apply LC-MS and GC-MS techniques to identify unknown compounds and solve complex analytical problems.
  • Plan and manage multidisciplinary research projects with guidance from subject matter experts and supervisors.
  • Interpret analytical data, communicate research outcomes, and contribute recommendations to broader pharmaceutical development programs.

Requirements

  • Master’s degree with 6–10 years of relevant experience, or PhD with 4–6 years of relevant experience.
  • Formal training and hands-on expertise in mass spectrometry, including accurate mass, MS/MS experiments, and data interpretation.
  • Strong knowledge of organic chemistry and analytical techniques such as chromatography, NMR, and IR.
  • Experience developing and validating complex quantitative LC-MS methods.
  • Ability to work independently, make routine and less-routine decisions, and communicate technical direction to junior associates.
  • Ability to work effectively with internal and external partners and solve problems using analytical chemistry expertise.

Nice to have

  • Experience with nitrosamine testing, extractables and leachables study design, environmental chemistry testing, or trace organic analysis.
  • Experience in a regulated pharmaceutical environment and knowledge of cGXP, quality system, and related regulatory requirements.
  • Background in multidisciplinary elucidation of unknown compound structures.

Culture & Benefits

  • Work within a culture emphasizing courage, trust, collaboration, ownership, and accountability.
  • Contribute to research supporting product registration and compliance with pharmaceutical regulations.
  • Reasonable accommodations are available for candidates with disabilities.

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