Director, MSAT

What will you do

• Leads the Manufacturing Science and Technology team and is responsible for process related activities enabling Drug Substance manufacturing of Biologic’s.
• Is responsible for facility fit assessment, tech transfer activities, coordination of process start-up activities including Engineering Runs, GMP/clinical, PPQ and routine commercial runs, and resulting risk mitigation activities.
• Is responsible for Process Validation and Continued Process Verification activities.
• Supports manufacturing activities with active process monitoring and data trending, process deviation resolution, process improvements and scientific expertise in the Drug Substance field.
• Provides strong technical leadership to process engineers, scientists and associates for clinical and commercial production.
• Covers scientifically and/or technically based process improvements of clinical and commercial manufacturing processes.
• Offers molecule steward and drive process lifecycle management initiative in accordance to customer’s molecular strategy as needed.
• Actively liaises with external customers and internal partners to facilitate execution of customer projects.
• Operates as key point of contact for Joint Steering Committees engaging with senior level executives both internally and externally.
• Represents the St. Louis site as a domain guide during external and internal regulatory compliance inspections.
• Supports the authoring, reviewing and approving of regulatory applications for customers as well as support responses to regulatory agencies.
• Builds and responsibly leads operational budgets for the MSAT organization of the site.
• Responsible for recruitment and development of MSAT staff, ensuring effective utilization of resources through strong leadership, performance management and robust employee development plans.
• Drives continuous improvements and establishes best-in-class MSAT capabilities by improving the enabling processes and systems.
• Works multi-functional with process development, manufacturing, quality assurance, quality control, supply chain, and facilities departments to effectively transfer, maintain and commercialize processes in the facility.
• Ensures that changes to existing processes or the introduction of new processes are carried out and documented according to approved change control procedures and in compliance with cGMP requirements.

How will you get here

• Education: PhD in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 8 years of relevant experience; or M.S./M.A. in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 12 years of relevant experience; or B.S./B.A. in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 14 years of relevant experience.
• Experience: 7 years of experience in a leadership role in sciences /technology groups in a fast-paced production environment. Broad experience in all process areas (Upstream cell culture, downstream processing, buffer and media preparation) and ancillary processes (CIP, SIP).
• Good GMP knowledge. A customer-centric mentality. Experience in leading teams and developing talent. Excellent organization, planning, problem solving and critical thinking skills. Excellent writing, communication and presentation skills. Willingness to travel up to 10%.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits!

Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.