Formulation & Development (Injectables) - Senior Research Associate

Job Summary

end-to-end formulation and development

Key Responsibilities

1. Pre-Formulation & Formulation Development

• Conduct pre-formulation studies: solubility, pH, compatibility, excipient screening.
  
• Develop sterile injectable formulations (IV, IM, SC, intrathecal, depot, etc.).
  
• Optimize formulations for stability, manufacturability, and regulatory requirements.
  
• Work on both

  small molecule and peptide/biologic injectables

  as applicable.

2. Process Development & Scale-Up

• Design and optimize formulation and filtration processes.
  
• Participate in scale-up activities: aseptic processing, sterilization, and filling.
  
• Support lyophilization cycle development for freeze-dried products.
  
• Troubleshoot process challenges and propose improvements.
  

3. Stability & Analytical Support

• Coordinate with Analytical Development for method development.
  
• Monitor and interpret stability data as per

  ICH guidelines

  .
• Evaluate critical quality attributes (CQA): pH, osmolality, particulates, assay, sterility, endotoxin, etc.
  

4. Documentation & Regulatory Compliance

• Prepare formulation development reports, study protocols, and SOPs.
  
• Document scale-up and technology transfer activities.
  
• Ensure compliance with

  cGMP, GLP, ICH, and regulatory

  requirements.
• Provide technical inputs for regulatory submissions (USFDA, EMA, WHO, etc.).
  

5. Cross-Functional Collaboration

• Work closely with QA, QC, Packaging, RA, Analytical Development, and Manufacturing teams.
  
• Participate in project review meetings and provide technical updates.
  

Qualifications

• M.Pharm

  in Pharmaceutics or Pharmaceutical Technology.

• 58+ years

  of experience in formulation development of injectable dosage forms.

Key Skills

• Strong hands-on experience with injectable formulation techniques.
  
• Knowledge of aseptic processing, sterilization, and lyophilization.
  
• Excellent understanding of ICH, cGMP, and regulatory requirements.
  
• Good analytical, documentation, and problem-solving skills.
  
• Ability to work independently and within cross-functional teams.