12 дней назад
Research Associate II – Nitrosamines (Characterization Team)
Мэтч & Сопровод
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Описание вакансии
Текст:
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
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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