Scientist /Senior Scientist (MD/MV)

Job Title: Scientist / Senior Scientist Pharma MD/MV

Experience: 3 to 7 Years

Location: Hyderabad (Shamirpet)

Job Objective: To develop, optimize, and validate robust analytical methods for drug substances (API) and drug products (Formulations). This role focuses on ensuring methods for Dissolution, Assay, and Purity meet global regulatory standards and support product stability studies.

Key Responsibilities:

• Method Development (MD): Design and develop stability-indicating methods for Assay, Related Substances (RS), and Dissolution. Select appropriate columns, mobile phases, and diluents.
• Method Validation (MV): Plan and execute validation protocols as per ICH Q2 guidelines, covering parameters like Accuracy, Precision, Specificity, Linearity, LOD/LOQ, and Ruggedness.
• Dissolution Studies: Perform complex dissolution method development for various dosage forms (Immediate, Sustained, or Delayed Release) using USP Apparatus I, II, and IV.
• Instrumentation: Hands-on operation and troubleshooting of HPLC, UPLC, and GC. Experience with Empower 3 software is mandatory.
• Stability & Forced Degradation: Conduct stress studies (Acid, Base, Peroxide, Thermal, and Photolytic) to ensure methods are stability-indicating.
• Documentation: Drafting Method Development Reports (MDR), Validation Protocols, and Validation Reports (PVR) in compliance with GLP/cGMP and Data Integrity standards.

Candidate Profile:

• Education: M.Sc. (Analytical/Organic Chemistry) or M.Pharmacy (Pharmaceutical Analysis/Pharmaceutics).
• Experience: 37 years of core experience in an Analytical R&D (AR&D) or Method Development lab.
• Soft Skills: Good technical writing skills and the ability to work within strict project timelines.