Associate Director, MSAT Product Lead

SERVIER MONDE

45d • Hybrid

About The Position

About Servier

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
This position will represent all MSAT functions in product-based Strategic Operations Teams (SOT) and coordinate inputs to strategic topics and communication to various stakeholders.
 

Requirements

• Bachelor ’s Degree with 10+ years of CMC/MSAT experience required; Master’s Degree with 8+ years of CMC/MSAT experience or PhD Degree with 5+ years of CMC/MSAT experience preferred
• CMC development and/or commercialization experience including support of submissions and launches
• Experience leading multidisciplinary technical team
• Technical expertise in manufacturing process and/or analytics with demonstrated understanding of end-to-end development and life cycle management topics
• Knowledge and experience with FDA and EMA regulatory CMC requirements
• Demonstrated ability to influence internal and external stakeholders across various functions
• Demonstrated excellence in writing, presentation, and overall communication in English
• Strong interpersonal skills and demonstrated accomplishments working in interdisciplinary teams within matrix organization setting
• Proficient with basic Project Management skills
• Ability to effectively operate in an environment that requires collaboration, influencing skills, negotiation skills, and analytical judgment

Responsibilities

• Represent all MSAT technical areas (Drug Substance, Drug Product, Packaging, Analytical) within the Strategic Operations Team (SOT) and collaborate with SOT representatives from IPNS, Manufacturing, QA, Procurement, Supply Chain, and other functions on topics impacting product strategy, lifecycle, and industrial performance.
• Provide MSAT assessments and recommendations on SOT topics related to new sites, technologies, manufacturing process and analytical methods, product stability, lifecycle management, tech transfers, capacity expansions, continuous improvements and regulatory-impacting changes.
• Report and escalate technical issues related to manufacturing processes and analytical methods requiring SOT visibility or escalation to governance bodies.
• Ensure MSAT alignment with product-related strategies and provide consolidated MSAT input and recommendations to SOT to support decision-making and long-term strategic planning.
• Proactively identify, propose, and support lifecycle management opportunities for the product (e.g., technical optimizations, risk reduction activities, cost-saving options), ensuring timely communication to SOT.
• Recommend technical strategies and estimated timelines for relevant projects related to commercial products, including approaches for analytical development/validation/transfer, manufacturing process development/feasibility/PPQ, stability, comparability considerations where applicable.
• Build and recommend alternative technical scenarios (technical pathways, risk mitigations) to support SOT decision making as needed.
• Coordinate with MSAT functions (and corresponding CMC counterparts as applicable) ensuring timely, high-quality inputs for robust technical recommendations related to product strategy.
• Communicate SOT outputs and program-level information to all relevant MSAT functions, ensuring a consistent flow of updates, decisions, risks, and upcoming priorities.
• Stay aware of all technical project plans (Drug Substance, Drug Product, Packaging, Analytical) through collaboration with MSAT Technical Team Leads and other stakeholders, ensuring accurate and timely information flows between MSAT and SOT.
• Establish and maintain MSAT product-specific risk registers and mitigation plans, proactively identifying risks and monitoring implementation of mitigations in collaboration with MSAT functions, escalating significant technical risks to SOT.
• Serve as the first point of contact to broader company stakeholders for high-level information regarding manufacturing processes and analytical methods as well as product-related technical topics.

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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees