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Associate - Formulation Analytical
Science Technology
💰 Salary Not shared
📊 Market ₹30,000–₹50,000/mo (₹360,000–₹600,000/yr)
About the Company
Since 1987, Eurofins has grown from one laboratory in Nantes, France to over 65,000 staff across a network of independent companies in 59 countries, operating over 950 laboratories. Performing over 450 million tests every year, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing. Ever since its IPO on the French stock exchange in 1997, Eurofins has been one of the fastest growing listed European companies. Biotechnology Research Specialties: Bioanalytical services, Food & Feed testing, Environment testing, Pharma Services, Pharma Early Development, Pharma Central Laboratory, BioPharma Product Testing & QC, Agrosciences, Product Testing, Genomic Services, Forensics & Applied Genetics, REACH Services
Responsibilities
- ● Develop, optimize, and validate analytical methods for New Chemical Entities and generic compounds using advanced instrumentation including HPLC-UV, GC, LC-MS/MS, and ICP-MS
- ● Ensure all methods meet regulatory requirements and are suitable for intended applications
- ● Perform dose verification analysis on preclinical dose formulation samples utilizing HPLC-UV, GC, and LC-MS/MS techniques
- ● Generate Certificates of Analysis for Investigational New Drug submissions with accuracy and attention to regulatory compliance
- ● Conduct routine calibration and maintenance of laboratory equipment including HPLC systems, pH meters, analytical balances, and pipettes in accordance with established protocols
- ● Maintain detailed calibration records and ensure all instruments remain within acceptable operating parameters
- ● Maintain comprehensive and secure raw data management practices in compliance with GLP/GMP standards
- ● Prepare and develop study protocols and Standard Operating Procedures to ensure consistency and regulatory adherence
- ● Maintain laboratory facilities and operations in full compliance with Good Laboratory Practice guidelines
- ● Support day-to-day laboratory operations while adhering to all quality and safety standards
- ● Collaborate with cross-functional teams to ensure timely completion of analytical projects
Requirements
- ● Master's degree in Chemistry, Pharmaceutical Sciences, or related discipline
- ● Minimum 3-4 years of professional experience in analytical chemistry, pharmaceutical formulation analysis, or related laboratory environment
- ● Demonstrated expertise in analytical instrumentation, including HPLC-UV, GC, LC-MS/MS, and ICP-MS
- ● Comprehensive knowledge of regulatory compliance standards, including GLP and GMP guidelines
- ● Proficiency in analytical method development, validation, and documentation in accordance with regulatory requirements
- ● Strong technical competency in data management and regulatory documentation practices
- ● Experience with IND submissions and preclinical analytical support is preferred
- ● Familiarity with pharmaceutical quality assurance protocols and Certificate of Analysis preparation is preferred
- ● Proven track record of maintaining compliance with regulatory standards in a pharmaceutical or contract research organization setting is preferred
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