Senior Director, MSAT

Thermo Fisher Scientific•St. Louis, MO

3d•Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. Location/Division: St. Louis, Missouri, Onsite PSG – Biologics How will you make an impact: The Senior Director, Manufacturing Sciences and Technology (MSAT), serves as the strategic and scientific leader for all technology transfer, process validation, continued process verification, product lifecycle management, and manufacturing process support activities for the St. Louis Biologics site. This role provides executive leadership for a highly complex biologics manufacturing operation supporting clinical and commercial drug substance programs across a diverse client portfolio. As a member of the site leadership team, the Senior Director is accountable for developing and executing the MSAT strategy to ensure successful commercialization of customer molecules, operational excellence, regulatory compliance, and sustainable business growth. The position leads an organization of 80+ scientists, engineers, managers, and technical professionals supporting multiple GMP manufacturing suites and commercial assets. This leader acts as the primary scientific and technical authority for manufacturing processes at the St. Louis site, partnering closely with customers, regulatory agencies, and senior Thermo Fisher leadership to deliver successful outcomes across the product lifecycle. The role directly influences site performance through technical risk management, process robustness, operational readiness, and continuous improvement initiatives that drive manufacturing efficiency, client satisfaction, and business profitability. The Senior Director serves as a trusted executive partner to global biotechnology and pharmaceutical clients, building long-term strategic relationships and providing scientific leadership through governance forums, Joint Steering Committees, regulatory interactions, and commercialization planning. They are responsible for ensuring successful technology transfers from development through commercial manufacturing while balancing customer expectations, site capabilities, regulatory requirements, and financial objectives. This role has significant responsibility for supporting site revenue growth and profitability through successful execution of customer programs, optimization of manufacturing processes, efficient deployment of technical resources, and achievement of key operational and financial performance metrics. The position contributes directly to site P&L performance through delivery of technology transfer milestones, commercial process optimization, capacity utilization improvements, and lifecycle management initiatives. In Biologics at Thermo Fisher Scientific, we deliver integrated solutions from process development through commercial supply, enabling clients to bring innovative therapies to patients worldwide. This role plays a critical leadership position in advancing our mission by ensuring robust, compliant, and scalable manufacturing processes that support life-changing biologic medicines.

Requirements

Ph.D in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 10 years of relevant experience; or M.S./M.A. in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 15 years of relevant experience; or B.S./B.A. in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 20 years of relevant experience.
Minimum 15+ years of progressive experience within biologics, biotechnology, pharmaceutical manufacturing, or CDMO environments, including significant experience supporting commercial operations.
Minimum 10 years of leadership experience managing large, multidisciplinary scientific and technical organizations through multiple levels of leadership.
Demonstrated success leading technology transfer, process validation, process performance monitoring, and lifecycle management activities for clinical and commercial biologics products.
Proven experience serving as a senior client-facing leader with responsibility for strategic customer relationships, governance interactions, and executive-level communications.
Experience supporting regulatory inspections and interactions with global health authorities, including FDA, EMA, MHRA, PMDA, Health Canada, and other international regulatory agencies.
Strong understanding of commercial biologics manufacturing operations, process characterization, process validation, continued process verification, and product lifecycle management principles.
Demonstrated financial acumen with experience managing large departmental budgets, resource planning, and contributing to business performance and P&L objectives.
Experience operating within a complex CDMO environment supporting multiple customers, products, and manufacturing platforms.
Proven track record of building high-performing organizations, developing leadership talent, and driving organizational transformation.
Willingness to travel up to 10%.

Responsibilities

Serve as the senior technical authority for manufacturing processes at the St. Louis biologics site, providing strategic direction across technology transfer, process validation, commercial support, and lifecycle management activities.
Lead and develop an organization of 80+ technical professionals through multiple layers of leadership, fostering a culture of accountability, innovation, technical excellence, and employee development.
Own the strategic roadmap for MSAT capabilities, ensuring alignment with site growth objectives, client needs, regulatory expectations, and Thermo Fisher's long-term business strategy.
Partners with Commercial, Program Management, and Business Development teams and support new business opportunities, client proposals, facility fit assessments, technical due diligence, and contract negotiations.
Act as executive sponsor and primary client-facing leader for key strategic accounts, building trusted relationships with senior client stakeholders and ensuring successful program execution throughout the product lifecycle.
Lead scientific and operational governance through Joint Steering Committees, Executive Business Reviews, and customer governance forums, representing the site with executive-level internal and external stakeholders.
Provide strategic leadership during regulatory inspections and customer audits, serving as the site's subject matter authority for process validation, technology transfer, process performance, and product lifecycle management programs.
Drive operational excellence initiatives that improve process robustness, manufacturing success rates, cycle times, capacity utilization, and overall site productivity.
Accountable for MSAT financial performance, including operating expense budgets, headcount planning, capital prioritization, resource allocation, and contributions to overall site profitability and P&L performance.
Champion cross-functional integration across Manufacturing, Process Development, Quality, Supply Chain, Engineering, Regulatory Affairs, and Commercial organizations to ensure seamless execution of client programs.
Influence network-wide technical strategy and best practices across Thermo Fisher's global biologics manufacturing organization