FRD- CephalosporinsPenem

Position Overview

We are seeking an experienced Formulation Research & Development (FRD) Scientist specializing in Cephalosporin and Penem injectable formulations. The role involves end-to-end development of sterile injectable products ensuring compliance with global regulatory standards and supporting technology transfer to manufacturing sites.

Key Responsibilities

• Formulation Development

  • Design and optimize formulations for Cephalosporin and Penem injectables (powder for injection lyophilized and ready-to-use solutions).
  • Conduct pre-formulation studies compatibility testing and stability evaluations.
  • Develop scalable processes for aseptic manufacturing.

• Analytical & Stability Studies

  • Collaborate with Analytical R&D for method development and validation.
  • Conduct accelerated and long-term stability studies as per ICH guidelines.
  • Interpret data to refine formulations and ensure product robustness.

• Regulatory & Documentation

  • Prepare technical documents: product development reports batch manufacturing records and technology transfer dossiers.
  • Support regulatory submissions (CTD modules ANDA/Dossier preparation).
  • Ensure compliance with GMP GLP and global regulatory requirements (USFDA EMA WHO).

• Technology Transfer

  • Coordinate with production teams for scale-up and commercial manufacturing.
  • Provide technical support during validation batches and regulatory inspections.

• Cross-functional Collaboration

  • Work closely with QA QC Regulatory Affairs and Manufacturing teams.
  • Liaise with external partners CROs and CMOs when required.

Desired Candidate Profile

• Education: (Pharmaceuticals Pharmaceutics or related discipline).
• Experience: 5–10 years in FRD with proven expertise in sterile injectable formulations specifically Cephalosporins and Penems.
• Technical Skills:
  • Strong knowledge of aseptic processing lyophilization and sterile filtration.
  • Familiarity with advanced analytical techniques (HPLC LC-MS particle size analysis).
  • Understanding of global regulatory requirements for injectables.
• Soft Skills:
  • Detail-oriented with strong documentation skills.
  • Ability to manage multiple projects and meet timelines.
  • Effective communication and cross-functional collaboration.