Project Manager Generics Manufacturing & Quality

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 bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization.

Position Title: Project Manager – Generics Manufacturing & Quality

Role description

Lead tracking & reporting of end-to-end execution of generics manufacturing and quality programs for commercial manufacturing. Drive cross-functional coordination to ensure timely delivery, regulatory compliance, product quality, supply continuity, and successful commercialization of generic pharmaceutical products.

Key Responsibilities

Program Management

• Develop and maintain integrated trackers, milestones, timelines, budgets, and governance dashboards.
• Track progress and ensure on-time delivery of key manufacturing, quality, regulatory, and supply chain deliverables.
• Lead operations reviews and provide management updates on risks, opportunities, and mitigation plans.
• Drive accountability across cross-functional teams to achieve project objectives.

Quality & Compliance

• Partner with Quality teams to ensure compliance with GMP, regulatory requirements, and company quality standards.
• Oversee project-related deviations, CAPAs, change controls, investigations, and quality risk management activities.

Cross-functional Leadership

• Collaborate with Manufacturing, QA, QC, Regulatory Affairs, MSAT, Supply Chain, Procurement, R&D, and External Manufacturing teams.
• Facilitate decision-making and issue resolution among stakeholders.
• Drive alignment across global and regional teams to meet business priorities.

Risk & Stakeholder Management

• Identify project risks and develop mitigation strategies.
• Escalate critical issues proactively and drive timely resolutions.
• Manage communication with senior leadership and present project progress, challenges, and recommendations.

Qualifications & Experience

• Bachelor's or Master's degree in Pharmacy, Biotechnology, Life Sciences, Chemical Engineering, or related discipline.
• 8–15 years of experience in pharmaceutical manufacturing, quality, technical operations, program management, or related functions.
• Proven experience managing complex pharmaceutical projects, preferably in generics manufacturing and commercialization.
• Strong understanding of GMP, regulatory requirements, technology transfer, validation, and quality systems.

Key Competencies

• Program & Portfolio Management (Must have)
• Manufacturing Operations (Must have)
• Quality Systems & Compliance (Must have)
• Risk Management (Must have)
• Regulatory Knowledge (Good to have)
• Leadership & Influencing Skills (Must have)
• Stakeholder Management (Must have)
• Problem Solving & Decision Making (Must have)
• Executive Communication (Must have)

Biocon Biologics is an Equal Opportunity, EEO / Affirmative Action Employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to, and no employee shall be discriminated against because of their race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.