Job Profile for Principle Scientist/Lead Scientist/Senior manager/Assistant General Manager
Candidate should be experience in Complex Injectable dosage form such as Liposomes, Microspheres, Nanoparticles, polymeric multi-particulate systems, Depot formulation, Suspensions, Lyophilized powders, colloidal suspension, and peptides/protein based formulations.
Years of experience: 10-15 years
Qualifications: M.Pharm (Pharmaceutics/Pharmaceutical Technology), Ph.D. (Preferred)
- Literature search, understanding of Quality by design, design of experiments, US-FDA product specific guidance, EMA guidelines, ICH guidelines, Statistical tools required in product development.
- Exposure of different software’s and tools required for QBD and DOE.
- Prototype formulation design to Lab scale development, process optimization using DOE and contemporary approach.
- Understating of complex APIs, Polymers, lipids and peptides APIs, Impurities.
- Characterization of complex formulations by advance techniques and interpretation of data. Understanding of DSC, AFM, DLS, SEM, TEM, Cryo-TEM,



Raman-Spectroscopy, NMR, PXRD, SAXS, Zeta Sizer.
- Should be experience in Lab scale, scale up and technology transfer of complex process for exhibit/validation at GMP sites, optimization of critical process parameters at large scales.
- Should be experience in preparations and review of protocols, reports and Product development reports, Manufacturing Formulation Records, BMRs, Products Specifications.
- Should be experience in Product development as per the regulatory requirements of US-FDA, MHRA, and EMA. Different filling stages to approval process. Regulatory queries handling, preparation of justification.
- Should be experience in Product development by QbD approach (QTPP, CQA, CMA, CPP), Risk assessment by FMEA.
- Should be experience in Team handling and experiment design, planning, data interpretation, complex analytical methods.
- Should be experience in GLP/GMP compliance requirements, Different SO

📌 Senior Manager-Injectable (Baska)
🏢 BDR GROUP
📍 Baska