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Process Development Lab

4 weeks ago

Ahmedabad, India Intas Full time

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.