If you are a biotechnology professional looking to advance your career in GMP manufacturing, this opportunity at Lupin Limited offers a strong platform. The company is hiring for the role of Executive โ GMP at its Pune Biotech facility, focusing on upstream mammalian manufacturing operations.
This role is ideal for candidates with hands-on experience in cell culture, media preparation, and GMP documentation who want to work in a highly regulated biopharmaceutical environment.
Job Overview
Job Title
Executive โ GMP
Location
Pune (Biotech Facility)
Experience Required
3 to 6 Years
Department
Biotech Manufacturing (Upstream โ Mammalian)
Roles and Responsibilities
The selected candidate will be responsible for managing upstream manufacturing operations and ensuring compliance with GMP standards.
Key Responsibilities:
- Execute operations of disposable, stainless steel, and glass bioreactors
- Perform media preparation, inoculum transfer, and subculture activities
- Carry out CIP (Cleaning in Place) and SIP (Sterilization in Place) processes
- Maintain accurate in-process records and perform sample analysis
- Prepare and review GMP documents such as:
- SOPs
- BPRs (Batch Production Records)
- Qualification & validation protocols
- Technology transfer documents
- Participate in process scale-up and technology transfer activities
- Coordinate with cross-functional teams including QC, QA, Engineering, Warehouse, MSAT, and R&D
- Execute equipment and process qualification activities
- Handle SAP transactions related to production
- Ensure readiness for internal and external audits
- Review executed documents including logbooks, protocols, and checklists
Required Qualifications
Educational Qualification
- Graduation in Biotechnology
- Post-Graduation in Biotechnology (preferred)
Experience
- 3 to 6 years in biotech or pharmaceutical manufacturing
- Hands-on experience in cell culture and GMP environment
Key Competencies
- Result Orientation
- Process Excellence
- Collaboration and Teamwork
Salary and Benefits
Estimated Salary Range
โน5.5 LPA โ โน9 LPA (based on experience and skills)
Benefits
- Opportunity to work in a leading biopharmaceutical company
- Exposure to advanced mammalian cell culture technologies
- Career growth in GMP and biotech manufacturing
- Training and development in regulatory compliance