API / Analytical Development Chemist - AG Consulting & Services - Biotech Recruitment Specialist : Job Details

Job Overview:

We are seeking a highly motivated and experienced Analytical Method Development Scientist to join our team in the development, optimization, and validation of analytical methods for the characterization and quality control of Active Pharmaceutical Ingredients (APIs) under Good Manufacturing Practice (GMP) guidelines. The successful candidate will work closely with cross-functional teams, ensuring that analytical methods are developed and validated in compliance with regulatory requirements and industry standards.

Key Responsibilities:

Analytical Method Development:

• Develop, optimize, and validate analytical methods for API testing, including but not limited to chromatography (HPLC, GC), spectroscopy (UV, IR, NMR), and other relevant techniques.
• Develop new techniques and strategies for API analysis to improve efficiency, accuracy, and robustness of testing processes.
• Ensure methods are robust, reproducible, and compliant with GMP, ICH, and regulatory requirements.

Regulatory Compliance:

• Ensure that all analytical methods meet industry standards and are compliant with GMP, GLP, ICH, and other applicable regulatory guidelines.
• Assist in the preparation of regulatory submission documents, including method validation reports and analytical data packages for regulatory filings (e.g., IND, NDA, ANDA).

Documentation & Reporting:

• Prepare and review documentation for method development and validation, including protocols, reports, and standard operating procedures (SOPs).
• Maintain accurate and comprehensive records of method development activities, results, and outcomes.
• Generate reports and summaries for internal and external stakeholders.

Qualifications:

Education:

• Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related field. A Ph.D. is a plus.

Experience:

• Minimum of 3-5 years of experience in analytical method development, particularly for APIs, within a GMP-compliant environment.
• Strong hands-on experience with various analytical techniques such as HPLC, GC, NMR, IR, UV-Vis, and titration methods.
• Experience in method validation, qualification, and transfer in accordance with regulatory guidelines (e.g., ICH Q2, USP).