Biocon Limited is a globally recognized, innovation-led organization that is enabling access to high quality, advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high.
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We are driven by the belief that the pharmaceutical industry has a humanitarian responsibility to provide essential drugs to patients who are in need and to do so with the power of innovation. In line with this belief, Biocon has developed and commercialized a differentiated portfolio of novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as, generic formulations in the U.S. and Europe. We are a leading global player for biosimilars and APIs for statins, immunosuppressants, and other specialty molecules, with customers in over 120 countries.
We have built an employee-friendly environment for our gender-diverse workforce that is comparable to the best in the world. This has been validated once again by our position among the Top 20 Best Employers in the Biotech Industry as ranked by the prestigious Science magazine. We have been recognized for being a socially responsible organization with loyal employees who are providing global leadership in innovation.
Position: Quality Head – Microbiology
Location: Bengaluru, Karnataka, India
At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long term commitment to bring high-quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization.
- Accountable for all India Quality Control – Microbiology operations
- Accountable for defining, setting up, executing, and continuously improving any related activity, including organizational and human aspects
- Lead and drive all operational Quality Control Microbiology activities per allocated perimeter, ensuring any products are tested with validated methods in a timely, cost-effective, efficient, and fully compliant manner at all times.
- Proactively identify issues and develop solutions in a collaborative multidisciplinary environment
- Enable prompt and effective decision making and troubleshooting of methods and reconciliation of atypical results. Provide direction to microbiology leaders to ensure project timelines are met.
- Define, implement, monitor testing strategy and plan for the allocated perimeter, defining appropriate metrics, relentlessly seeking and implementing best practices or any improvements
- Ensure consistency, standardization, efficiency, and cost-effectiveness of approaches
- Enhancement of sterile assurance and ensure compliance across the microbiology function
- Be an effective communicator of ideas, organization goals, and results to team members across cross-functional roles and departments.
- Ensure proper organizational design to best meet customers needs
- Lead, manage, develop, and coach the team, fostering the right behaviors and mindset
- Closely interacts with all business functions to ensure effective contribution to BBIL ambition, including the continuous supply of products to market, launches, and submissions
- Lead cross-functional initiatives, proactively support other QLT members where needed
- Represent Global Quality at cross-functional leadership meetings, and committees, as necessary
Technical / Functional Skills
- Experience and expertise in the EM, Aseptic processing & Sterility Assurance
- Experience with analytical method development, transfer, and validation for drug substance and drug product release and stability testing is required.
- Extensive experience in facing regulatory audits and knowledge of governing regulations and GMPs is required
Good understanding of Lean principles (Green Belt certification preferred)
Qualification: M. Sc./Ph.D./Pharm.D. or equivalent in a relevant scientific discipline
Experience: 15-20 years of experience in multinational pharma/biopharma companies, with strong background in Microbiology/ Biotechnology, Biochemistry and significant exposure to EMA and US FDA requirements
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