Program Management - Biosimilar

Biocon Biologics; Bengaluru; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Biocon Biologics, Bengaluru, seeks a senior program leader to drive end-to-end biosimilar development across R&D, Clinical, Regulatory and Manufacturing, ensuring delivery within cost and timelines while meeting global regulatory expectations.

You will coordinate cross-functional teams, manage CRO/CMO partners, govern programs, budgets and risk mitigation, with 12+ years in biopharma and biosimilar pathway expertise.

Qualifications

• Master's or PhD in Life Sciences, Biotechnology, or Pharmacy.
• 12+ years in biopharmaceutical industry with biosimilar development experience.
• PMP certification is preferred.

Responsibilities

• Lead integrated program planning across CMC, clinical, regulatory, and supply chain.
• Drive governance forums and executive 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.
• Coordinate development, strategy discussions, clinical studies execution.
• Manage CRO and CMO engagements and timelines.
• Lead cross-functional alignment across internal and external partners.
• Manage CMOs/CROs and contractual deliverables.
• Identify risks and implement mitigation strategies.
• Enable data-driven decision making.

Skills

Cross-functional leadership

Strategic thinking

Communication

Influencing skills

Program management

Financial management

Education

Master's / PhD in Life Sciences / Biotechnology / Pharmacy

PMP certification

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:

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

Program Governance & Execution

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

Budget & Financial Management

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

Regulatory Strategy Alignment

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

R&D and Clinical Oversight

• Coordinate development, strategy discussions, clinical studies execution etc.
• Manage CRO and CMO engagements and timelines, as may be necessary.

Stakeholder Management

• Lead cross-functional alignment across internal and external partners
• Manage CMOs/CROs and contractual deliverables

Risk & Decision Management

• Identify risks and implement mitigation strategies
• Enable data-driven decision making

Academics Background:

• Master's / PhD in Life Sciences / Biotechnology / Pharmacy
• PMP preferred

Experience Required:

• 12+ years in biopharmaceutical industry
• Demonstrated experience in biosimilar development programs

Competencies

• 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