Associate Director Biosimilar Technical Support

ADVANZ PHARMA; Mumbai; On-site; INR 3,500,000 - 6,500,000; Full time

Benefits offered by this job

Competitive compensation

Global exposure

Growth opportunities

Job summary

ADVANZ PHARMA is seeking an Associate Director - Biosimilars Technical Services to provide technical leadership across our biosimilars portfolio, driving product development, commercialization, supply continuity and lifecycle management.

The role demands deep expertise in biologics manufacturing, tech transfer, CMC and regulatory alignment, with 15+ years in pharma and 10+ years in biosimilars operations, and strong leadership of multi-disciplinary teams.

Qualifications

• Master's degree in Pharmacy, Chemistry, or related scientific discipline.
• 15+ years of pharmaceutical/biotech experience with 10+ years in biologics/biosimilars operations.
• Strong leadership, project management, stakeholder management, and problem-solving abilities.
• Deep understanding of ICH guidelines and regulated market requirements.
• Prince2 Certification and MS Project knowledge preferred.

Responsibilities

• Serve as technical lead for biologics and biosimilars across development, manufacturing, packaging, and commercialization.
• Drive resolution of manufacturing, packaging, quality, compliance, and supply challenges to ensure uninterrupted product availability.
• Provide strategic technical expertise and risk assessments for launches, lifecycle management, tech transfers, and supply initiatives.
• Lead cross-functional decision-making on manufacturing deviations, product disposition, release considerations, and product write-offs.
• Collaborate with CDMOs, supply chain, quality, regulatory, and partners to deliver products successfully.
• Oversee biosimilar batch planning, manufacturing operations, testing, release activities, and commercial supply readiness.
• Identify, assess, and mitigate technical and operational risks; implement continuous improvement initiatives.
• Support due diligence, acquisitions, integrations, and business-critical projects with technical evaluation and execution.
• Develop and maintain SOPs, technical processes, and governance frameworks for compliance and excellence.
• Manage technical services budgets, resource planning, and performance metrics to support business objectives.
• Build, mentor, and develop a high-performing technical services team through training and capability development.
• Monitor operational performance, drive efficiency, and collaborate with stakeholders to improve processes.
• Ensure compliance with global regulatory requirements, ICH guidelines, and industry best practices for biologics and biosimilars.

Job description

ADVANZ PHARMA is a global pharmaceutical company dedicated to improving patients' lives through specialty, hospital, and rare disease medicines. We are looking for a highly experienced Associate Director - Biosimilars Technical Services to provide technical leadership across our biosimilars portfolio and support product development, commercialization, supply continuity, and lifecycle management.

Key Responsibilities

• Serve as the technical lead for biologics and biosimilar products across development, manufacturing, packaging, and commercialization activities.
• Drive the resolution of critical manufacturing, packaging, quality, compliance, and supply-related challenges to ensure uninterrupted product availability.
• Provide strategic technical expertise and risk assessments for product launches, lifecycle management, tech transfers, and supply chain initiatives.
• Lead cross-functional decision-making on manufacturing deviations, product disposition, release considerations, and product write-offs.
• Collaborate closely with CDMOs, supply chain, quality, regulatory, commercial, and external partners to ensure successful product delivery.
• Oversee biosimilar batch planning, manufacturing operations, testing, release activities, and commercial supply readiness.
• Identify, assess, and mitigate technical and operational risks while implementing sustainable solutions and continuous improvement initiatives.
• Support due diligence, product acquisitions, integrations, and business-critical projects with timely technical evaluation and execution.
• Develop and maintain SOPs, technical processes, and governance frameworks to ensure compliance and operational excellence.
• Manage technical services budgets, resource planning, and performance metrics to support business objectives.
• Build, mentor, and develop a high-performing technical services team through training, coaching, and capability development.
• Monitor operational performance, identify process improvements, and drive efficiency through strong stakeholder collaboration.
• Ensure compliance with global regulatory requirements, ICH guidelines, and industry best practices for biologics and biosimilars.
• Champion a culture of accountability, innovation, agility, and collaboration aligned with ADVANZ PHARMA's core values of Entrepreneurship, Speed, and Integrity.

What We're Looking For

• Master's degree in Pharmacy, Chemistry, or a related scientific discipline
• 15+ years of pharmaceutical/biotech experience, including 10+ years in biologics or biosimilars technical operations
• Strong expertise in biologics manufacturing, fill-finish, tech transfer, CMC, lifecycle management, and CDMO oversight
• Deep understanding of ICH guidelines and regulated market requirements
• Proven leadership, project management, stakeholder management, and problem-solving abilities
• Prince2 Certification and MS Project knowledge preferred

Why Join ADVANZ PHARMA?

• Work with a global organization operating across 20+ countries
• Strong career growth and internal mobility opportunities
• Inclusive and entrepreneurial culture
• Competitive compensation and benefits
• Make a meaningful impact on patients' lives worldwide