Program Manager

Company: Biocon Biologics
Location: Bengaluru, Karnataka, India
Experience: 8–15+ years
Work Mode: On-site
Job Type: Full-time

Job Overview

Biocon Biologics is seeking an experienced Program Manager to lead end-to-end generic drug substance and drug product development programs. The role requires integrated program leadership across R&D, CMC, clinical, regulatory, supply chain, and manufacturing functions, ensuring delivery against agreed timelines, budgets, and global regulatory expectations for advanced markets.

Key Responsibilities

Program Governance and Execution

• Lead integrated program planning across CMC, device management, clinical, regulatory, and supply chain functions.

• Drive program governance forums, milestone tracking, executive reporting, and cross-functional execution.

Budget and Financial Management

• Own program budgets, forecasting, and cost optimization.

• Conduct budget variance analysis and provide financial insights to support program decisions.

Regulatory Strategy Alignment

• Align development activities with applicable US FDA, EMA, and global generic drug substance and drug product requirements.

• Support regulatory filing strategies and product lifecycle management.

R&D and Clinical Oversight

• Coordinate development strategies, R&D activities, and clinical study execution.

• Manage CRO and CMO engagements, deliverables, and timelines where required.

Stakeholder and Partner Management

• Lead alignment across internal functions and external partners.

• Manage CRO/CMO relationships and contractual deliverables.

• Facilitate decisions and maintain effective stakeholder communication.

Risk and Decision Management

• Identify program risks and implement mitigation plans.

• Enable data-driven decision-making and proactively resolve execution challenges.

Required Qualifications and Experience

• Master's degree or PhD in Life Sciences, Biotechnology, or Pharmacy.

• 8–15+ years of experience in the biopharmaceutical industry.

• Demonstrated experience leading generic drug substance and drug product development programs.

• Strong understanding of US and European regulatory pathways relevant to generics development.

• Advanced program and financial management capabilities.

• Proven cross-functional leadership, stakeholder management, communication, and influencing skills.

• Strong strategic thinking and problem-solving abilities.

Preferred Qualification

• Project Management Professional (PMP) certification preferred.

Key Performance Indicators

• On-time milestone delivery.

• Budget adherence and variance control.

• Regulatory submission success.

• Effectiveness of risk mitigation.

• Stakeholder satisfaction.

Leadership Expectations

• Ownership and accountability.

• Collaboration and stakeholder alignment.

• Agility and adaptability.

• Continuous improvement mindset.

Compensation

Not disclosed in the supplied job listing.