[Hiring] Associate Director, Biologics Drug Substance @SERVIER MONDE

Role Description

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
• 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.

Qualifications

• 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

Requirements

• 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
• 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

Benefits

• Salary range: $150,000 - $211,000
• Short-Term and Long-Term incentive programs
• Medical, dental, vision insurance
• Flexible time off (unlimited sick time and flex time)
• 401(k) plan
• Life and disability insurance
• Recognition programs
• Comprehensive benefits package (subject to eligibility requirements)

Company Description

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.

At Servier, you will collaborate with a highly skilled, international team dedicated to bringing the promise of tomorrow to the patients we serve today.