Process Development Lab (Injectable) - Research Associate

Job Overview:

The PDL Scientist - Injectable will be responsible for the development, optimization, and scale-up of sterile injectable formulations and manufacturing processes. The role demands expertise in injectable formulation science, process engineering, and compliance with regulatory and quality standards.

Role & responsibilities

• Formulation Development:

• Design and optimize sterile injectable formulations, including solutions, emulsions, and suspensions.
  
• Perform compatibility and stability studies of active pharmaceutical ingredients (APIs) with excipients.
  

• Process Optimization:

• Develop robust, scalable manufacturing processes for injectable formulations.
  
• Define and optimize critical process parameters (CPP) and quality attributes (CQA).
  

• Sterility Assurance:

• Establish aseptic processes and ensure compliance with sterility requirements.
  
• Perform filtration studies, autoclave cycle development, and validation.

• Analytical Support:

• Collaborate with the analytical team for the development and validation of testing methods.
  
• Conduct particle size analysis, pH, and osmolarity evaluations, and other critical tests.
  

• Regulatory Compliance and Documentation:

• Prepare technical reports, batch records, and regulatory submissions in compliance with GMP, ICH, and FDA guidelines.
  
• Support regulatory inspections and audits with comprehensive process documentation.
  

• Technology Transfer:

• Facilitate the transfer of processes from lab-scale to manufacturing-scale environments.
  
• Work closely with cross-functional teams, including production, quality assurance, and regulatory affairs.

Preferred candidate profile

• 3 - 5 years of experience in injectable formulation and process development.
  
• Hands-on experience with lyophilization, sterilization techniques, and aseptic manufacturing processes.

• Strong knowledge of GMP, ICH, and regulatory guidelines.
  
• Proficiency in using laboratory equipment such as autoclaves, lyophilizes, and HPLC systems.
  
• Excellent technical writing and documentation skills.