Associate Director Biosimilar Technical Support

Role Overview

Key Responsibilities

• Lead biologics and biosimilar technical activities across development, manufacturing, packaging, and commercialization.
• Resolve manufacturing, packaging, quality, compliance, and supply challenges.
• Provide technical expertise and risk assessments for launches, lifecycle management, technology transfers, and supply-chain initiatives.
• Lead decisions involving deviations, product disposition, release considerations, and write-offs.
• Collaborate with CDMOs, supply chain, quality, regulatory, commercial, and external partners.
• Oversee batch planning, manufacturing, testing, release, and commercial supply readiness.
• Identify and mitigate technical and operational risks and drive continuous improvement.
• Support due diligence, acquisitions, integrations, and business-critical projects.
• Develop SOPs, technical processes, and governance frameworks.
• Manage budgets, resource planning, and performance metrics.
• Build and develop the technical-services team.
• Monitor operational performance and improve efficiency.

What We Are Looking For

• Master's degree in Pharmacy, Chemistry, or a related scientific discipline.
• At least 15 years of pharmaceutical or biotechnology experience, including at least 10 years in biologics or biosimilars technical operations.
• Strong expertise in biologics manufacturing, fill-finish, technology 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 are preferred.

Workplace

• The role is based in Andheri, Mumbai, with a flexible hybrid working model.

Company Context

• ADVANZ PHARMA operates globally across more than 20 countries.
• The company describes career growth, internal mobility, an inclusive culture, and competitive compensation and benefits.