Senior Manager Biotech Formulation Development
2 days ago
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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