Servier Pharmaceuticals · 1 hour ago
Associate Director, MSAT Product Lead
Boston, KY
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$150K/yr - $180K/yr
8+ years expServier Pharmaceuticals is a Boston-based, commercial-stage biopharmaceutical company focused on advancing cutting-edge science. The Associate Director, MSAT Product Lead will represent all MSAT functions in product-based Strategic Operations Teams and coordinate inputs to strategic topics while collaborating with various stakeholders on product strategy and lifecycle management.
Health CareMedicalPharmaceutical
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
Qualification
Required
Bachelor 's Degree with 10+ years of CMC/MSAT experience required
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
Preferred
Master's Degree with 8+ years of CMC/MSAT experience or PhD Degree with 5+ years of CMC/MSAT experience preferred
Benefits
Short-Term and Long-Term incentive programs
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
Company
Servier Pharmaceuticals
Servier Pharmaceuticals is a pharmaceutical company dedicated to therapeutic progress to serve patient needs.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
David K. Lee
Chief Executive Officer
Pedro Crisanto
Chief Operating Officer R&D, USA
Recent News
2025-12-08
Company data provided by crunchbase