Required Experience
HPLC / GC method development for OSD having exposure to regulated, Semi Regulated & India markets including : Complex generic, F2F, Topical & Dermaceuticals, Peptides, Oncology
NI / GI & NDSRI' with LCMS / GCMS expertise, Solid state characterization.
Job Description
- To develop analytical method for Assay, Related Impurity (Degradation Product), Content uniformity, Dissolution and other related tests
- Dissolution testing and evaluation.
- Analyzing API, formulation and raw materials
- Performing pre-formulation analysis
- To analyze API trials and formulation trials
- To analyze stability samples of development trials
- Literature review for drug substance (API) and drug Product (Formulation)
- To prepare reference and working standards
- Preparation of Analytical Method Development Report
- Preparation of analytical methods and COA (Certificate of analysis)
- To update instrument log book entries
Skills Required
Api, Lcms, Testing