Associate - Formulation Analytical

Job description

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

Prepare for the interview

Nothing collected for this employer yet. The Blind 75 is what technical screens draw from; practise it here, with a coach, in Java or Python.

More at Eurofins

• Assistant Project Manager (Entry Level) - Eurofins Drinking Water and Wastewater Central, Hunstville, TX · Huntsville, TX, United States
• Test Operator/Assembler · Santa Clara, CA, United States
• Assistant Scientist · Hercules, CA, United States
• Mechanical Assembly Technician · Houston, TX, United States
• Program Coordinator · Remote; Des Moines, IA, United States
• Molecular Profiling Scientist · South San Francisco, CA, United States
• Associate Product Manager - Drug Discovery Solutions · Fremont, CA, United States
• Analytical Scientist – Protein Characterization · Gaithersburg, MD, United States

More like this

• Associate jobs in Bengaluru, India (3)