Associate Director, Biologics Drug Substance

About Servier

With commercial stage products and a promising pipeline, we are Servier Group means becoming part of a unique global organization headquartered in France, driven by commercial-stage products and a promising pipeline. Operating in more than 150 countries and governed by a non-profit foundation, we are proud to have multiple approved medicines in oncology and other disease states worldwide. We have significantly accelerated our investments with a clear ambition: to further establish ourselves as leaders and innovators in Oncology.

Currently, over half of our research and development efforts are dedicated to delivering major advances in targeted therapies for patient communities with high unmet needs. At Servier, you will collaborate with a highly skilled, international team dedicated to bringing the promise of tomorrow to the patients we serve today

Within Servier Industry, the Global Manufacturing Science and Analytical Technology (MSAT) organization plays a key role in driving technical excellence, industrial transformation, and lifecycle management - enabling manufacturing robustness, quality, and compliance across all product modalities and technologies.

Role Summary

Reporting to the Director of Drug Substance (Biologics), MSAT, this role is an individual contributor position and will serve as a subject-matter expert (SME) in upstream and downstream processes for outsourced drug-substance manufacturing, technology transfer, life cycle management, and global regulatory submissions of complex Biologics, monoclonal antibodies, enzymes, bi-specifics, ADCs, and recombinant therapeutics.

The incumbent is responsible for overseeing all drug-substance manufacturing activities at the CMO site, including process scale-up, technology transfers, validations, PPQ campaign support, continuous process improvements, and post-approval lifecycle management of commercially approved products. The position also involves collaborating with various SMEs from MSAT, QA, QC, CMC, External Manufacturing, internal sites, and CMC Regulatory.

Primary Responsibilities

Technical Oversight & Manufacturing Support

• Serve as primary technical interface with global CMOs supporting Drug Substance manufacturing.
• Lead investigations for technical deviations, root cause analyses, and CAPA implementation.
• Supervise campaign readiness, change management, and process development discussions.
• Lead internal technical meetings and contribute to Virtual Plant Teams (VPTs) to manage timelines, supply impact, risks, and budget.

Technology Transfer, Scale-Up & Validation

• Oversee process scale-up, technology transfer, PPQ readiness, and validations across CMO sites
• Author and review validation protocols, reports, and technical documentation.
• Drive continuous improvement initiatives across upstream and downstream processes
• Drive standardization and knowledge-sharing practices across sites and the global network.

Lifecycle Management & CPV

• Own lifecycle management strategies for assigned commercial products across manufacturing sites.
• Establish and maintain robust process monitoring and Continuous Process Verification (CPV) strategies.
• Perform statistical analysis on campaign data to create and analyze process trends and control charts.

CMC & Regulatory Support

• Author and review CMC sections for global regulatory submissions (NDA, BLA, MAA, ND, IPMD)
• Support filing in new markets and impact assessment to post-approval changes.
• Support responses to health authority questions related to manufacturing processes and controls.
• Ensure manufacturing and validation strategies align with GMP, ICH, and global regulatory expectations.

Technical Leadership & SME Role

• Lead process risk and criticality assessments to identify gaps and define improvements.
• Support business development and technical due diligence activities as needed.
• Stay current with scientific literature, evolving technologies, and MSAT best practices.

Education and Required Skills

Academic Background:

• Ph.D. with 5 years of experience or M.S. with 8 years of experience preferred, B.S. with 10 years of experience required in Chemical Engineering, Biochemistry, Biotechnology, Synthetic Organic chemistry…