As part of the Analytical R&D team, your role centers around the identification, analysis, and control of Nitrosamine impurities in pharmaceutical products. Nitrosamines are potential carcinogenic substances, and regulatory agencies (like the FDA and EMA) have set strict limits for their presence in drug substances and products.
Responsibilities:
Risk Assessment:
Conduct Nitrosamine risk evaluations for drug substances (API) and drug products in accordance with ICH, FDA, and EMA guidelines.
Analytical Method Development:
Develop and validate sensitive and robust analytical methods (typically GC-MS, LC-MS/MS) to detect and quantify Nitrosamine impurities.
Root Cause Investigation:
Work cross-functionally with Process R&D and Manufacturing to identify the sources of Nitrosamine formation and suggest mitigations.
Regulatory Support:
Prepare and review documents for regulatory submissions, including method validation reports and Nitrosamine risk assessments.
Instrument Handling:
Operate and maintain high-end analytical instruments like LC-MS/MS, GC-MS, and Orbitrap/HRMS as needed.
Compliance & Documentation:
Ensure all activities are performed in compliance with Good Laboratory Practices (GLP) and company SOPs. Maintain accurate and timely documentation.
Interested candidates, please send your resumes to hr.advinus@advinus.eurofinsasia.comwith the subject line: “Analytical R&D – Nitrosamines Bangalore”
About Eurofins Advinus
Eurofins Advinus is a research and development services provider that facilitates the discovery and advancement of compounds across various sectors, including pharmaceuticals, biologics, agrochemicals, nutraceuticals, and cosmetics. As a part of Eurofins Scientific, a leading global laboratory group with revenues of €6.72 billion, Eurofins Advinus offers a comprehensive range of analytical testing services to industries such as pharmaceuticals, food, environment, and consumer products, as well as to governmental bodies.
With over three decades of Good Laboratory Practice (GLP) experience, Eurofins Advinus conducts regulatory studies adhering to international standards, supporting clinical trials and the global registration of substances and products. For the pharmaceutical and biotech industries, the company provides end-to-end services in areas like preclinical toxicology testing, chemical process development, analytical research and development, drug metabolism, and pharmacokinetics, all crucial for Investigational New Drug (IND) submissions. Additionally, Eurofins Advinus offers long-term non-clinical toxicology testing, including carcinogenicity studies, to support New Drug Applications (NDA).
Beyond pharmaceuticals, Eurofins Advinus extends its analytical, toxicological, and chemical services to meet regulatory submission requirements for other industries, such as agrochemicals, cosmetics, nutraceuticals, and industrial chemicals.
As a pioneer in drug discovery services in India, Eurofins Advinus has established significant collaborations with global pharmaceutical leaders like Takeda, Merck, Johnson & Johnson, Novartis, Celgene, and the Drugs for Neglected Diseases initiative (DNDi), demonstrating its commitment to advancing healthcare solutions worldwide.
