Sr. Manager - F&D Injectable

Role & responsibilities:

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.

• 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 softwares and tools required for QBD and DOE.
• Prototype formulation design to Lab scale development, process optimization using DOE and modern 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 SOPS of Development Lab.
• Understanding of Pre-clinical studies, Bio equivalence studies, clinical studies (phases)

Preferred candidate Qualification

M. Pharm (Pharmaceutics/Pharmaceutical Technology), Ph.D. (Preferred)

Position Details

• Position: Sr. Manager - F&D
• Location: Baska (Vadodara)
• Reporting: Vice President - F&D
• Required Experience: 12-15 years