- Develop, validate, and troubleshoot analytical methods for drug substances and drug products.
- Define analytical control strategies and implement methodologies throughout development stages.
- Collaborate closely with process development teams (drug substance and drug product).
- Manage all analytical activities at R&D labs.
- Lead and mentor junior analysts.
The ideal candidate must also have a strong background in organic impurities in drug substances and drug products, as well as experience in forced degradation studies, method validation and method transfer between laboratories.
Preferred Qualifications:
- Prior experience with the development and characterization of small molecules, peptides, or oligonucleotides.
- Familiarity with analytical techniques for immediate- and controlled-release oral solid dosage forms.
- Experience with LC-MS/MS systems and their application in trace-level impurity analysis or bioanalytical method development is highly desirable.
A Master’s degree in Science or Pharmacy.At least 10 years of practical experience in pharmaceutical companies.Solid understanding of small molecule analysis, structure elucidation, and solid-state characterization.Hands-on experience with techniques such as LC-MS, HPLC, NMR, FTIR, UV, GC, particle size analysis, and thermal analysis.Knowledge of USP/ICH/FDA guidelines, particularly related to analytical method validation, impurity profiling, and stability testing.Demonstrated ability in preparing method validation reports, protocols, specifications, and regulatory documentation.Familiarity with GLP, GMP, and phase-appropriate quality systems.Excellent communication and technical writing skills.Strong leadership and team management abilitiesExcellent problem-solving and troubleshooting skills