Associate Director - Operations

Michael Page; Mumbai; On-site; INR 3,500,000 - 7,500,000; Full time

Benefits offered by this job

Permanent role

Leadership opportunity

Mumbai-based role

Job summary

Michael Page, a pharmaceutical organisation based in Mumbai, is seeking a senior leader to drive end-to-end biosimilars operations, shaping strategy across development, manufacturing and commercialization.

As the primary technical SME, you will oversee DS/DP development, tech transfers, lifecycle management and product launches, coordinating with CDMOs and global cross-functional teams to ensure GMP compliance and on-time supply.

Qualifications

• 15+ years total experience with at least 10 years in biosimilar/biologic technical role (DS/DP development, tech transfer, production) within pharma/biotech, preferably for regulated markets.
• Excellent collaboration and communication abilities.
• Strong technical knowledge base of biosimilar/biologic products from development to commercial scale CMC.

Responsibilities

• Lead end-to-end technical oversight of the biosimilars portfolio across development, manufacturing, and commercialization activities.
• Serve as the primary technical SME, supporting manufacturing, packaging, quality, regulatory, and supply chain functions.
• Drive technology transfers, product launches, lifecycle management, and integration of acquired products.
• Manage relationships with CDMOs and external manufacturing partners to ensure uninterrupted product supply.
• Lead investigations and resolution of manufacturing, quality, compliance, and supply-related challenges.
• Ensure GMP compliance, technical governance, risk management, and continuous process improvement across products.
• Collaborate with global cross-functional teams to support regulatory submissions, product changes, and market expansion initiatives.
• Provide leadership to the technical services team, including performance management, capability building, and execution of strategic objectives.

Job description

• Lead global biosimilar operations and shape strategy
• Strategic role with broad technical and commercial exposure

About Our Client

This is a pharmaceutical organisation based in Mumbai.

Job Description

• Lead end-to-end technical oversight of the biosimilars portfolio across development, manufacturing, and commercialization activities.
• Serve as the primary technical SME, supporting manufacturing, packaging, quality, regulatory, and supply chain functions.
• Drive successful technology transfers, product launches, lifecycle management, and integration of acquired products.
• Manage relationships with CDMOs and external manufacturing partners to ensure uninterrupted product supply.
• Lead investigations and resolution of manufacturing, quality, compliance, and supply-related challenges.
• Ensure GMP compliance, technical governance, risk management, and continuous process improvement across products.
• Collaborate with global cross-functional teams to support regulatory submissions, product changes, and market expansion initiatives.
• Provide leadership to the technical services team, including performance management, capability building, and execution of strategic objectives.

The Successful Applicant

We're looking for someone who has:

• A strong background in technical operations, manufacturing and formulation in the pharmaceutical industry.
• Minimum 15 years of overall experience with at least 10 years hands on experience in biologics or biosimilar technical role (Drug substance / Drug product/ Formulation and fill finish - development / Tech transfer / Production / LCM) within the pharmaceutical or biotechnology industry preferably for regulated markets.
• Excellent technical knowledge base of biosimilar or biologic sterile pharmaceutical products from development of DS/ DP to commercial scale CMC aspects.
• Good understanding of biosimilar batch planning, manufacturing, packaging, testing and release arrangement with knowledge of product distribution and supply especially working with CDMOs.
• Excellent collaboration and communication abilities.

What's on Offer

• A permanent role in a respected pharmaceutical organisation.
• Opportunity to work in a key leadership position.
• Based in Mumbai with a focus on technical operations.