Eurofins·5 days ago
5 days ago
Associate - Formulation Analytical
Sign up free to see how well your resume matches this role.
What you'll do
- Develop, optimize, and validate analytical methods for New Chemical Entities (NCEs) 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 (CoA) for Investigational New Drug (IND) 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 (SOPs) to ensure consistency and regulatory adherence
- Maintain laboratory facilities and operations in full compliance with Good Laboratory Practice (GLP) 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
What they're looking for
- Master's degree (M.Sc. or M. Pharm.) 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
Nice to have
- Experience with IND submissions and preclinical analytical support
- Familiarity with pharmaceutical quality assurance protocols and Certificate of Analysis (CoA) preparation
- Proven track record of maintaining compliance with regulatory standards in a pharmaceutical or contract research organization (CRO) setting
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Job Description
Key Responsibilities
Analytical Method Development & Validation
- Develop, optimize, and validate analytical methods for New Chemical Entities (NCEs) 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
**Preclinical Analysis & Quality Assurance**
- Perform dose verification analysis on preclinical dose formulation samples utilizing HPLC-UV, GC, and LC-MS/MS techniques
- Generate Certificates of Analysis (CoA) for Investigational New Drug (IND) submissions with accuracy and attention to regulatory compliance
**Equipment Calibration & Maintenance**
- 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
**Regulatory Compliance & Documentation**
- Maintain comprehensive and secure raw data management practices in compliance with GLP/GMP standards
- Prepare and develop study protocols and Standard Operating Procedures (SOPs) to ensure consistency and regulatory adherence
- Maintain laboratory facilities and operations in full compliance with Good Laboratory Practice (GLP) guidelines
**Laboratory Operations**
- 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
Qualifications
Qualifications
- Master's degree (M.Sc. or M. Pharm.) 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
Preferred:
- Experience with IND submissions and preclinical analytical support
- Familiarity with pharmaceutical quality assurance protocols and Certificate of Analysis (CoA) preparation
- Proven track record of maintaining compliance with regulatory standards in a pharmaceutical or contract research organization (CRO) setting
Company
Eurofins
Bengaluru, India
Company facts come from this company's own listings. We only show what the postings themselves carry.