MSAT Analytical Development lead (Oral Drugs - Onco-Neurology) Expert
We are a human-sized, international, and independent pharmaceutical group, governed by a Foundation. Our unique model is a source of pride, but above all, it allows us to fully serve our mission: “Committed to therapeutic progress for the benefit of patients.”
Today, a global leader in cardiology, we have chosen to become a focused and innovative player in oncology by 2030, targeting hard-to-treat cancers and dedicating more than 70% of our R&D budget to this area. We are committed to equal opportunities and the development of talent in all its diversity. We value both experience and the willingness to engage daily to contribute to therapeutic progress for the benefit of patients. If you see yourself reflected in this offer and these few lines, seize the opportunity to meet us. We pursue this challenge alongside the development of our generics business, ensuring access to quality care for all, at a lower cost.
Who are we? More than 20,000 passionate individuals from over 50 nationalities, driven by an entrepreneurial spirit. Every day, we move forward with and for patients, with and for our teams, guided by the desire to care, to take risks, to grow, and to commit ourselves to be useful to those in need.
Role based in France (Bolbec/Le Havre/Rouen, or Gidy/Orleans or Paris/Suresnes) or Ireland (Arklow) or Poland (Varsow) - Domestic and international travel up to 20%
Within Servier Industry, the 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.
Role Summary
Reporting to the MSAT Analytical Technology Lead, Oncology/ Neurology Products (Oral Dosage forms), this role will serve as an analytical subject matter expert (SME) for commercial Oncology/ Neurology Products (Oral Dosage forms), responsible for the analytical method lifecycle management, method transfers, validations, verifications and troubleshooting at external and internal manufacturing/testing sites.
Primary Responsibilities
- Analytical point of contact to support commercial manufacturing at active pharmaceutical ingredients (APIs), and Oncology/ Neurology Products (Oral Dosage forms) forms at CMOs and method transfers to external/ internal sites.
- Responsible for the day-to-day oversight of analytical activities at the CMO and support site-based MSAT Analytical teams if applicable.
- Responsible for analytical life cycle management (method development, validation, control strategy, transfers, release and stability testing) at the CMO.
- Responsible to collaborate with the internal sites, as required, to support the analytical life cycle management of the Servier products.
- Manage and review deviation events and OOS/OOT investigations at CMOs and internal sites in coordination and collaboration with QA/QC team, as appropriate.
- Support regulatory filing - author/ review CMC-related sections for regulatory filings for the new markets and work with regulatory to respond to regulator's inquiries.
- Represent analytical function in project team meetings and work closely with cross-functional teams to meet project timelines and goals.
- Actively participate in internal virtual plant team and joint technical team meetings.
Education : Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry or Medicinal Chemistry or related discipline with 5 years of relevant experience or a Master's degree with 7 years of relevant experience working in the Oral Dosage products.
Technical skills :
- In-depth theoretical and extensive hands-on experience in various analytical techniques and instrumentations.
- Previous experience in solid-state analysis, physical characterization, and drug product dissolution.
- Strong background in method development, validation, and routine analysis for Nitrosamine impurities in drug product test samples.
- Knowledge of industry USP/ICH guidance for the development, qualification/ validation of analytical methods
- Previous experience in analytical control strategy development and execution.
- Previous experience in drafting and reviewing analytical sections of regulatory submissions, including new and post-approval changes (MAA/NDA and Variations), as well as responding to health authority queries.
- Experience in use/application of basic statistical methodologies and software’s (e.g., Minitab, JMP or equivalent)
Soft skills :
- Excellent organizational skills: Proactive, management of multiple tasks of varied complexity simultaneously.
- Excellent communications and presentation skills – written and verbal
- Good listening and writing skills in English
- Ability to work in a team-oriented environment that embraces change, risk, and flexibility
We are committed to equal opportunities and the development of talent in all its diversity. We value both experience and the willingness to engage daily to contribute to therapeutic progress for the benefit of patients. If you see yourself reflected in this offer and these few lines, seize the opportunity to meet us