Associate Director, Biologics Drug Substance

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 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. 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 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 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 Deep understanding of single‑use technologies, microbiology, Extractables and Leachables (E&L) Scale‑down models (SDMs), 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 (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. Travel and Location Preferred location is in Boston, US but will consider remote applicants Domestic and international travel up to 20% Job Description Candidate Profile Servier’s Commitment Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Salary Range The salary range for this role is $150,000 - $211,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short‑Term and Long‑Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as 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 among other great benefits (all benefits are subject to eligibility requirements). For more information on our benefits, please visit this link . #J-18808-Ljbffr Servier