Associate Director, Biologics Drug Substance

Associate Director, Biologics Drug Substance

About Servier

With commercial stage products and a promising pipeline, Servier Group is a unique global organization headquartered in France. Operating in more than 150 countries and governed by a non‑profit foundation, we have multiple approved medicines worldwide. We are primarily focused on oncology and other disease states, serving patients with high unmet needs.

Role Summary

Reporting to the Director of Drug Substance (Biologics), MSAT, this individual‑contributor position serves as a subject‑matter expert in upstream and downstream processes for outsourced drug‑substance manufacturing, technology transfer, life‑cycle management, and global regulatory submissions of complex biopharmaceuticals.

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 to manage timelines, supply impact, risks, and budget.
• 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 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 post‑approval changes impact assessment.
• 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 or Pharmaceutical Sciences.

Technical Expertise

• Extensive hands‑on experience in upstream (microbial fermentation & mammalian cell culture) and chromatography, UF/DF, viral clearance, depth filtration techniques in protein purifications.
• Proven experience with bioconjugation techniques, linker‑payload development, HPAPIs for clinical/commercial ADC manufacturing is desirable.
• Experience in synthesis, purification, and characterization of antibody drug conjugates and enzymes is preferred.
• Deep understanding of single‑use technologies, microbiology, extractables and leachables, scale‑down models, DoE, QbD, regulations, and process control strategy.

Regulatory and Compliance

• Proven track record in drafting and reviewing regulatory filings (MAA/NDA/BLA and variations) and responding to health authority queries.
• Experience in authoring/reviewing dossier sections & reports. Strong understanding of cGMP & ICH guidelines.

Data Analysis and Problem Solving

• Expertise in data management, statistical, and visualization tools such as JMP or Minitab.
• Advanced proficiency in problem‑solving frameworks (Ishikawa, Kepner‑Tregoe, 5‑Whys).
• Proven experience collaborating with CMOs and external partners.
• Proficient in strategic planning and managing multiple complex projects simultaneously.
• Strong negotiation and influencing skills with the ability to work effectively in…