Director, Analytical Technology, MSAT Onc/Neuro Products

SERVIER MONDE

47d • Hybrid

About The Position

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision. Job DescriptionCandidate ProfileRole Summary
Reporting to the Head of Analytical Technology - MSAT, this global role leads a team of subject matter experts (SMEs) responsible for the analytical oversight of raw materials to active pharmaceutical ingredients (APIs) and Oral Solid Dosage (OSD) Oncology and Neurology drug products. This includes analytical method lifecycle management, method transfers, validations, verifications and troubleshooting across internal and external manufacturing sites.
The incumbent will also support site-based MSAT Analytical teams if applicable, and partner with site Quality Control departments to ensure consistent, robust, and compliant analytical performance. This is a key global analytical leadership position where the incumbent in collaboration with MSAT Leadership Team will contribute to shaping Servier’s Global MSAT function in alignment with corporate and Industry vision, driving innovation, continuous improvement, sustainability, and global collaboration for the Oncology and Neurology OSD portfolio.

Requirements

• Ph.D. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a related field with a minimum of 7 years of experience in the pharmaceutical industry or M.S. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences with a minimum of 10 years of experience in the pharmaceutical industry preferred. B.S. in Chemistry or a related field with a minimum of 12 years of experience in the pharmaceutical industry required.
• Demonstrated ability to coach and develop direct reports
• Consistently demonstrating growth mindset, adapting to and championing change, with a passion for building capabilities, to help shape the future of MSAT within a transforming organization.
• Experience in relationship management of Contract Research Organizations and contract laboratories.
• Extensive experience in the analysis of solid dosage forms, including HPLC, GC, KF, IC, LC-MS, UV-Vis, XRPD, DSC, FT-IR, SEM, optical microscopy, and microbial analysis.
• Proficient in solid-state analysis, physical characterization, and drug product dissolution.
• Experience in method development, validation, and routine analysis for Nitrosamine impurities in drug product test samples.
• Strong background in analytical control strategy development and execution.
• Previous experience in drafting and reviewing analytical sections of regulatory submissions, including new submissions (e.g., NDA/MAA) and post-approval Variations, as well as responding to health authority queries.
• Strong strategic thinking capabilities with a forward-looking perspective and demonstrated learning agility with a drive to solve problems.
• Excellent organizational, program management, and planning skills; adaptive learning, critical thinking, and the ability to work well in a team environment.
• Ability to work in a team-oriented environment that embraces change, risk, and flexibility.
• Excellent English communication skills – written and verbal, with strong presentation skills to create and deliver summaries and reports as needed.
• High proficiency in Word, Excel, PowerPoint, SmartSheet and statistical software (JMP, Prism).

Responsibilities

• Lead the analytical strategy for Servier’s commercial small molecule Oncology and Neurology products, including project strategy, setting priorities, establishing team goals, and ensuring timely and high-quality deliverables for internal and external programs.
• Provide strategic leadership to SMEs supporting internal, external manufacturing sites and site-based MSAT analytical teams, as applicable, to develop, validate, and transfer analytical methods for drug substances and drug products in support of commercial supply.
• Collaborate with MSAT Business Operations and Portfolio team to ensure appropriate prioritization and resource allocation to ensure successful delivery of SOT objectives across internal and external sites as applicable.
• Collaborate closely with CMC counterparts, who lead development-stage activities for pipeline assets, and ensure effective technical transition from CMC SMEs to MSAT as part of new product commercialization.
• Contribute to the preparation of global regulatory submissions, including new and post-approval changes, with clear and accurate source documentation, control strategy, and justification of specifications, comparability studies, and stability studies according to subject matter understanding and regulatory guidelines.
• Build and maintain strong collaborations across the organization, including key stakeholders in Global Manufacturing, CMC, Regulatory and Quality teams, peers, and senior management.
• Systematically identify gaps and risks across analytical methods and implement appropriate mitigations/improvements that ensure robust analytical testing across product lifecycle and facilitate uninterrupted commercial supplies
• Support internal and external audits, inspections, pre-approval activities, and maintain a state of continuous readiness across the product portfolio.
• Evaluate new technologies and sites as needed
• Support Due Diligence of external opportunities as needed
• Stay current with industry trends, scientific literature, and evolving technologies related to OSD analytics and MSAT best practices.

Benefits

• Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements).
• For more information on our benefits, please visit this link.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 251-500 employees