Department:- Formulation Development Injectable - NDDS

Designation:- Manager / Sr. Manager

Total experience: - 12+ years

Total Openings:- 01

Position Overview

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.

Roles & Responsibilities:
Exposure of different softwares 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 GLP/GMP compliance requirements, Different SOPS of Development Lab.
Understanding of Pre-clinical studies, Bio equivalence studies, clinical studies (phases)

📌 Sr Manager Formulation Development Injectable Ndds Halol
🏢 BDR Pharmaceuticals
📍 Halol