External Manufacturing

Biocon Biologics; Bengaluru; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Biocon Biologics is seeking an External Manufacturing Regional Operations Lead to manage day-to-day operations with regional contract manufacturing partners, ensuring reliable product supply, quality, and compliance. The role collaborates with Supply Chain, Quality, Regulatory, and Commercial teams for timely delivery.

Key responsibilities include managing CMOs/CDMOs, risk mitigation, capacity planning, and cross-functional coordination to align timelines and launches across Biocon’s biosimilars

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmaceutical Sciences, Engineering, or a related field. MBA or equivalent qualification is a plus.
• Minimum 10 years in the pharmaceutical/biotech industry, incl. 5+ years in external manufacturing or contract manufacturing management.

Responsibilities

• Partner Management: Build strong relationships with CMOs, CDMOs, and key vendors.
• Risk Management: Identify and address risks related to supply, quality, compliance, and partner performance.
• Supply Delivery: Ensure timely supply of biologic products from external manufacturers.
• Operational Excellence: Drive improvements in quality, cost, efficiency, and execution at partner sites.
• Capacity Planning: Review partner capacity and support plans for future demand and growth.
• Cross-Functional Coordination: Align timelines, submissions, launches, and supplies with Quality, Regulatory, R&D, Supply Chain, and Commercial.

Skills

Leadership

Partner Management

Communication

Problem Solving

Analytical

Decision Making

Cross-functional Collaboration

GMP Knowledge

Global Stakeholder Management

Education

Bachelor/Master degree

Job description

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 proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.

About the Role

External Manufacturing Regional Operations Lead will manage day-to-day operations with regional-based contract manufacturing partners. The role will ensure reliable product supply, quality, compliance, and strong partner performance across Biocon’s biologics portfolio

The role will work closely with Supply Chain, Quality, Regulatory, Commercial, and other internal teams to ensure smooth coordination and timely delivery

Key Responsibilities

• Partner Management: Build strong working relationships with CMOs, CDMOs, and key third-party vendors.
• Risk Management: Identify and address risks related to supply, quality, compliance, and partner performance.
• Supply Delivery: Ensure timely supply of biologic products from external manufacturers to meet market needs.
• Operational Excellence: Drive improvements in quality, cost, efficiency, and execution at partner sites.
• Capacity Planning: Review partner capacity and support plans for future demand and business growth.
• Cross-Functional Coordination: Work with Quality, Regulatory, R&D, Supply Chain, and Commercial teams to align on timelines, submissions, launches, and supply priorities.
• Issue Resolution: Proactively resolve operational, quality, regulatory, and supply issues with internal teams and external partners.
• Reporting: Provide clear updates on KPIs, partner performance, risks, milestones, and key actions.
• Team Leadership: Lead, guide, and develop team members while promoting accountability and collaboration.
• Talent Development: Support capability building and career development within the team.

Qualifications & Experience

• Education: Bachelor’s or Master’s degree in Life Sciences, Pharmaceutical Sciences, Engineering, or a related field. MBA or equivalent qualification is a plus.
• Experience: Minimum 10 years in the pharmaceutical or biotechnology industry, including at least 5 years in external manufacturing, supply chain, or contract manufacturing management.
• Technical Knowledge: Good understanding of biologics manufacturing, GMP requirements, and relevant regulatory expectations.
• Partner Management: Proven experience working with CMOs, CDMOs, and supply chain partners.
• Leadership: Ability to lead teams, influence stakeholders, and manage priorities in a global environment.
• Core Skills: Strong communication, problem-solving, analytical, and decision-making skills.