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