Group Leader Formulation R&D- Sterile

Company Description Sri Krishna Pharmaceuticals Ltd (SKPL), established in 1974, is a vertically integrated manufacturer of key APIs, PFIs, and finished dosage drugs, and is among the world’s largest producers of paracetamol. The company plays a significant role in the global pharma supply chain, with growing capabilities in bulk API synthesis, direct compression, intermediates, and finished dosage formulations. SKPL R&D Centre (Formulations), designated as Unit-VII and located in Chennai, Tamil Nadu, focuses on the research and development of medicinal products and the transfer of process and analytical technologies to manufacturing sites. The center is equipped for formulation and analytical development of solid oral dosage forms, direct compressible granules, and injectables, supporting registrations in markets such as the UK, Canada, Australia, and the European Union.
Positions: 2 (1 immediate)
Location: Chennai, Tamil Nadu
Experience: 7-8 years of experience in the pharmaceutical industry, specifically in formulation development for injectable drug products.
Qualification: Masters degree in Pharmaceutical Sciences
Department: Formulation Research and Development (FRD)
Job Summary:
We are seeking a highly motivated and talented formulation development scientist to join our Formulation Research and Development (FRD) team, focusing on the development of injectable drug
Key Responsibilities:
• To execute Pre-formulation studies, bench scale batches using different formulation processes.
• To support and execute the tech transfer activities and pilot batch manufacturing at manufacturing site.
• Coordination and correspondence for the arrangement of API, RLD, Excipients, Punches and other accessories for Lab scale batches.
• Coordination with cross functional departments like RA, QA, QC and ARD.
• Should have knowledge of parenteral dosage form development.
• Should have good knowledge of FR&D equipments and their handling.
• Responsible for conducting literature search, lab-scale batches, scale-up batches etc.
• Should have exposure in patents and regulatory framework.
• Must be able to prepare development documents like Master Formula Records (MFR/MPR), development protocols, and pharmaceutical development report.
• Need to be develop the products by QbD fashion. Expertise in DoE studies and interpretation using competent software is desirable.
• Willingness and Cooperation to work at Contract Manufacturing Organization (CMO) sites.
Additional Qualifications:
• Experience with a variety of injectable dosage forms such as solutions, lyophilized products, suspensions and emulsions.
• Should understand cGMP, ICH guidelines, and regulatory requirements (FDA, EMA).
• Hands-on experience with lab-scale and pilot-scale manufacturing processes for injectable products.
• Knowledgeable in formulation techniques such as lyophilization and aseptic processing.

Work arrangement
No