Associate Director, Biologics Drug Substance

SERVIER MONDE • Boston, MA

3d • $150,000 - $211,000 • Remote

About The Position

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. 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.

Requirements

• 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.
• Extensive hands-on experience in upstream (microbial fermentation & mammalian cell culture) and chromatography, UF/DF, Viral clearance, Depth filtration techniques in protein purifications.
• Deep understanding of single-use technologies, microbiology, Extractables and Leachables (E&L) Scale-down models (SDMs), DoE, QbD, regulations, and process control strategy.
• 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
• Expertise in data management, statistical, and visualization tools such as JMP or Minitab.
• Advanced proficiency in problem-solving frameworks (e.g., 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 interdisciplinary teams.
• Excellent skills in drafting development reports, summaries, and technical presentations.
• Excellent verbal and written English skills, including active listening, attention to detail, and the ability to draft technical reports and presentations.
• Ability to thrive in dynamic environments that embrace change, risk, and flexibility.

Nice To Haves

• Proven experience of working 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

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• medical
• dental
• vision
• flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off)
• 401(k)
• life and disability insurance
• recognition programs
• Short-Term and Long-Term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree