MSAT Analytical Specialist, DS and DP Synthetic

About the Job

The Analytical Technical Leader serves as SME supporting the MSAT Synthetics platform, providing comprehensive CMC analytical support for new product introductions, through life‑cycle development, and manufacturing assistance. The position coordinates analytical studies and programs at both internal MSAT centers and CDMOs, and is responsible for the overall analytical control strategy for new products. The role supports analytical technology transfers, method development and optimization, commercial product analytical support, planning and executing analytical study protocols, data analysis and stability trending, regulatory dossier development, and responses to registration questions.

The leader serves on the MSAT Technical Product Team (TPT) and supports M&S sites and External Manufacturing Quality and QC teams. Regular travel to internal and contract sites is required.

• Supports MSAT Synthetics DS & DP Leads as Analytical SME related to CMC for industrial activities for new product developments and commercial products.
• Supports technical issues relating to quality control and stability of pharmaceutical drug products and API.
• Coordinates and supports analytical project needs conducted at internal support centers and external contract laboratories.
• Defines and executes activities, contributing to overall CMC programs, for new projects and manufacturing support programs for product portfolio.
• Acts as a member of Technical Product Teams (TPT) and CMC Project Teams.
• Supports technology transfer of new and existing analytical methods for new products and product line extensions.
• Conducts laboratory investigations / troubleshooting for new and existing products.
• Activities span internal MSAT Centers, industrial sites, and CMOs.
• Collaborates with MSAT & R&D colleagues, External Manufacturing, Regulatory and Quality teams, third‑party manufacturing sites, and Sanofi sites that manufacture small‑molecule dosage forms for global markets.
• Technical work includes review of documentation, study initiation, follow‑ups, data review and summary, and report writing.
• Performs data trend analysis.
• Provides visits to internal M&S sites, development centers, contract labs and CMOs as required.
• Plans, coordinates and executes analytical activities with other MSAT Development centers, external laboratories and CMO manufacturing sites and Sanofi M&S sites.
• Prepares analytical testing protocols and budget plans for analytical activities requested by various Sanofi internal and external sites.
• Supports development plans of new products, product line extensions, analytical upgrades and manufacturing technical transfers of Sanofi products.
• Provides review for analytical method development, analytical method validation, associated reports and required stability studies, including trending analysis, in compliance with ICH/FDA guidelines.
• Provides guidance and review of CMC analytical responses prepared by the MSAT and M&S team members requested by regulatory agencies.
• Attends and participates in ongoing CRO/CMO manufacturing site planning and progress meetings as well as analytical testing evaluations and laboratory studies.

• CMA Project Team
• CMC DS sub‑team
• CMC DP sub‑team
• CMC platform M&S platform
• Tech Transfer Leader

• CMC Team Tech Transfer Governance
• Technical Review Board
• Technical Project Team
• Technical Review Meetings
• Scientific & Strategic Advisory Meeting (SSAM)
• CMC Board

Basic Qualifications

• Masters Degree in Pharmaceutical Sciences, Life Sciences, Chemistry or related fields.
• 7+ years of experience in Regulatory CMC, Process/Pharmaceutical Manufacturing Development, Analytical Science, or related fields.
• Confirmed experience in project management, working in a project team, and in a complex environment.
• Understanding of current pharmaceutical environment trends, scientific and regulatory challenges.
• Strong understanding and experience with cGMP requirements.
• Experience in leading international and/or multi‑cultural teams.

• High‑Performance Liquid Chromatography (HPLC) – Experienced/Advanced
• Dissolution Testing – Experienced/Advanced
• Mass Spectrometry (MS) –…