Associate Director, Oral Solid Drug Product
SERVIER MONDE · Boston
Job description
About the role
Servier’s Manufacturing Science and Analytical Technology (MSAT) team is seeking an Associate Director to lead technical stewardship for oncology and neurology oral solid drug products. The role provides scientific and process expertise across internal sites and external CMOs, ensuring robust manufacturing and lifecycle management.
Key responsibilities
- Provide technical oversight of manufacturing processes for assigned oral solid products at internal sites and CMOs, participating in virtual plant teams.
- Lead cross‑functional technical teams, manage meeting agendas, minutes and action items, and align project timelines, supply impact and budgets.
- Direct deviation investigations, root‑cause analyses and CAPA definition, and maintain continued process verification (CPV) across sites.
- Lead technology transfers, scale‑up changes, process performance qualification (PPQ) and launch readiness activities globally.
- Author or review CMC sections of regulatory submissions and support health‑authority queries.
Required profile
- Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering or related field with at least 8 years of relevant experience, or a Master’s/PhD with 6 years of experience in drug‑product formulation and process development.
- Demonstrated experience leading tech transfers, deviation investigations, change controls and preparing regulatory documentation for commercial products.
- Strong ability to work in a global matrixed environment with cross‑functional teams (Quality, Manufacturing, Supply Chain, Regulatory).
Required skills
- Formulation of immediate‑release and extended‑release oral solid dosage forms.
- Process expertise in blending, dry/roller compaction, wet/high‑shear granulation, fluid‑bed coating, tablet compression, tablet coating and capsule filling.
- Knowledge of primary container‑closure components for oral solid products.
- Use of statistical software such as Minitab or JMP.
- Application of problem‑solving tools (Ishikawa, Kepner‑Tregoe, five‑whys) and risk assessment methods (FMEA, CPV).
- Implementation of PAT tools (NIR, weight/force monitoring, in‑line content estimation).
What we offer
- Salary range $162,000 – $185,000 per year, plus short‑term and long‑term incentive programs.
- Comprehensive benefits including medical, dental, vision, unlimited sick time and flexible time off.
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Published 1 week ago
Expires 1 month from now
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SERVIER MONDE
Boston