MSAT Analytical Specialist, DS and DP Synthetic

About the role

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 involves coordinating analytical studies and programs at both internal MSAT centers and CDMOs. The leader is responsible for the overall analytical control strategy for new products and supports analytical technology transfers, method development and optimization and commercial product analytical support. The role also encompasses planning and executing analytical study protocols, conducting data analysis and stability trending as well as supporting regulatory dossier development and responses to registration questions. The individual will serve on the MSAT Technical Product Team (TPT) and support M&S sites and External Manufacturing Quality and QC teams. Regular travel to internal and contract sites is required.

Responsibilities

• Serves as SME supporting the MSAT Synthetics DS & DP Leads 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.
• Covers analytical project needs that are 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.
• Serves as a member of Technical Product Teams (TPT) and CMC Project Teams.
• Supports technology transfer of new and existing analytical methods, for new products, product line extensions.
• Conducts laboratory investigations / troubleshooting for new and existing products. Activities span both internal MSAT Centers and Industrial sites as well as CMOs.
• Collaborates with MSAT & R&D colleagues, External Manufacturing, Regulatory and Quality teams in addition to third party manufacturing sites, and Sanofi sites which 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.
• Visits to internal M&S sites, development centers and contract labs and CMOs are 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 the 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. This includes review and input 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 the regulatory agencies.
• Attends and participates in the ongoing CRO/CMO manufacturing sites planning and progress meetings as well as analytical testing evaluations and laboratory studies.

Qualifications

• Masters Degree in Pharmaceutical Sciences, Life Sciences, Chemistry or other related fields.
• 7+ years of experience Regulatory CMC, Process / Pharmaceutical Manufacturing Development, Analytical Science, or other related fields.
• Confirmed experience in project management, in working in project team and in complex environment (e.g., transversal assignments across different sites).
• Strong understanding and previous experience and training on cGMP requirements.
• Experience and understanding of current pharmaceutical environment including the economic and regulatory challenges.
• Experience in leading international and/or multi-cultural teams.

Skills

• High-Performance Liquid Chromatography (HPLC) (Experienced/Advanced)
• Dissolution Testing (Experienced/Advanced)
• Mass Spectrometry (MS) (Intermediate/Experienced)
• Manufacturing Process Improvements (Experienced/Advanced)
• Integrated Planning (Experienced/Advanced)
• Method Development (Experienced/Advanced)
• Analytical Testing (Experienced/Advanced)
• Method Validation (Experienced/Advanced)
• GMP Compliance (Experienced/Advanced)
• Risk Management (Experienced/Advanced)
• Standards Compliance (Experienced/Advanced)
• Project Management (Experienced/Advanced)
• Strategy Development (Experienced/Advanced)
• Stakeholder Communications (Experienced/Advanced)
• Technology Transfer (Experienced/Advanced)

Transversal Skills

• Cross-Functional Teamwork (Experienced/Advanced)
• Collaborative Communications (Intermediate/Experienced)