Analytical Development Scientist
Analytical Development Scientists design and validate analytical methods that support formulation and process development. Their work ensures the accurate characterization and control of pharmaceutical products during development and scale-up.
Key responsibilities:
Developing HPLC, GC, UV, and dissolution methods – Supporting API and finished product testing.
Validating analytical methods – Following ICH Q2(R2) guidelines for accuracy, precision, and specificity.
Supporting formulation and process teams – Providing data for compatibility, stability, and scale-up studies.
Troubleshooting instrumentation and results – Ensuring consistent, reliable outputs and method robustness.
Documenting in compliance with GMP and regulatory standards – Contributing to CMC sections of regulatory filings.
This role requires strong problem-solving skills, attention to detail, and hands-on experience in analytical chemistry.