Microbiology Head

BIOCON BIOLOGICS

- 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.

Role Summary :

Mission :

- 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

Role/Job Description :

- 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 the 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 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)

Background and Experience Required :

- M. Sc./Ph.D./Pharm.D. or equivalent in a relevant scientific discipline

- 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

- Experience in managing large teams is required

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