Senior Manager Biotech Formulation Development

2 days ago


Mumbai, Maharashtra, India Ipca Laboratories Limited Full time

Job Overview:

We are seeking a highly skilled Senior Manager for our Biotech Formulation Development team at Ipca Laboratories Limited in Mumbai.

Estimated Salary Range: ₹25,00,000 - ₹35,00,000 per annum based on qualifications and experience.

Job Description:

  • Biologics Formulation Development: Lead the development of new biologics formulations, including liquid and lyophilized products, to achieve project targets.
  • Lab Supervision: Oversee laboratory operations to ensure successful replication and scale-up of drug product processes.
  • Equipment Qualification and Calibration: Ensure equipment is qualified and calibrated to meet cGMP requirements.
  • Audit Participation: Participate in internal audits, vendor/service provider audits, and CMO audits.
  • Manufacturing Support: Handle deviations, change controls, investigations, root cause analysis, and CAPA.
  • Process Development: Develop DOE-based process development for lyophilized/liquid drug products.
  • Stability Studies: Plan and execute stability studies for drug products, FT cycle development, and forced degradation studies.
  • Data Compilation: Compile data for presentations and report preparation.
  • Laboratory Maintenance: Maintain lab equipment, materials, and consumables.
  • Support to Lab Management: Assist with laboratory management activities as required.
  • Primary Container Closure Assessment: Assess primary container closure and device for final drug products.


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