Sr Manager Formulation Development Injectable - NDDS

BDR Pharmaceuticals; Panchmahal District; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

BDR Pharmaceuticals in Gujarat, India seeks a Manager/Sr. Manager for Formulation Development Injectable - NDDS with 12+ years of experience.

The role focuses on complex injectable dosage forms like liposomes, microspheres and nanoparticles, with emphasis on QBD, DOE and regulatory readiness. The candidate will drive lab-scale design, process optimization, and technology transfer to GMP sites, coordinating with QA and regulatory teams to support drug product development and standard operating

Qualifications

• Experience in complex injectable dosage forms including liposomes, microspheres, nanoparticles, depot formulations and lyophilized powders.
• Knowledge of QbD, DfE and regulatory alignment to US-FDA, MHRA and EMA requirements.
• Proven ability to design labs-to-plant scale-up and tech transfer for GMP sites.

Responsibilities

• Exposure to tools for QBD and DOE.
• Prototype formulation design for lab-scale development and process optimization using DOE.
• Understand complex APIs, polymers, lipids and peptides; identify impurities.
• Characterize complex formulations with advanced techniques and data interpretation.
• Lead or support lab-to-plant scale-up and tech transfer for GMP exhibit/validation.
• Prepare protocols, reports, BMRs and product development documents.
• Address regulatory queries and justify development decisions.

Skills

QBD & DOE exposure

Lab scale development

Technology transfer

Regulatory knowledge

QbD approach

Tools

DSC

AFM

DLS

SEM

TEM

Cryo-TEM

Raman

NMR

PXRD

SAXS

Zeta Sizer

Job description

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 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 GLP/GMP compliance requirements, Different SOPS of Development Lab.
• Understanding of Pre-clinical studies, Bio equivalence studies, clinical studies (phases)