Program Manager - Biosimilar Development

Biocon Biologics; Bengaluru; On-site; INR 4,500,000 - 6,500,000; Full time

Job summary

Biocon Biologics seeks a senior leader to drive end-to-end biosimilar development programs across R&D, Clinical, Regulatory and Manufacturing in Bengaluru. You will ensure delivery aligns with cost, timelines and global regulatory expectations for advanced markets.

The role requires strong cross-functional leadership, advanced program and financial management, and deep knowledge of US/EU regulatory biosimilar pathways.

Qualifications

• Master’s or PhD in Life Sciences / Biotechnology / Pharmacy.
• PMP certification preferred.
• 13+ years in biopharmaceutical industry.
• Demonstrated experience in biosimilar development programs.
• Advanced program and financial management skills.
• Strong understanding of biosimilar regulatory pathways (US/EU).
• Cross-functional leadership and stakeholder management.
• Excellent communication and influencing skills.
• Strategic thinking and problem solving.

Responsibilities

• Lead end-to-end biosimilar development programs across R&D, Clinical, Regulatory, and Manufacturing.
• Manage program governance, budgeting, and reporting.
• Own program budget, forecasting, and cost optimization.
• Deliver variance analysis and financial insights.
• Align with FDA, EMA, and global biosimilar guidelines; support filing strategy and lifecycle management.
• Manage CROs/CMOs engagements and timelines as necessary.
• Lead cross-functional alignment across internal and external partners; identify risks and mitigation.

Skills

Cross-functional leadership

Stakeholder management

Communication

Strategic thinking

Problem solving

Education

Master’s or PhD in Life Sciences / Biotechnology / Pharmacy

PMP certification

Tools

PMP (certification)

Job description

Lead end-to-end biosimilar development programs across R&D, Clinical, Regulatory, and Manufacturing. Ensure delivery aligned to cost, timelines, and global regulatory expectations for advanced markets.

Key Accountabilities

1. Program Governance & Execution

• Lead integrated program planning across CMC, clinical, regulatory, and supply chain
• Drive governance forums and executive reporting

2. Budget & Financial Management

• Own program budget, forecasting, and cost optimization
• Deliver variance analysis and financial insights

3. Regulatory Strategy Alignment

• Align with FDA, EMA, and global biosimilar guidelines
• Support filing strategy and lifecycle management

4. R&D and Clinical Oversight

• Manage CRO and CMO engagements and timelines, as may be necessary.

5. Stakeholder Management

• Lead cross-functional alignment across internal and external partners
• Manage CMOs/CROs and contractual deliverables
• Identify risks and implement mitigation strategies

Education & Experience

• Master’s / PhD in Life Sciences / Biotechnology / Pharmacy
• PMP preferred
• 13+ years in biopharmaceutical industry
• Demonstrated experience in biosimilar development programs
• Advanced program and financial management skills
• Strong understanding of biosimilar regulatory pathways (US/EU)
• Cross-functional leadership and stakeholder management
• Excellent communication and influencing skills
• Strategic thinking and problem solving