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Director of Manufacturing Sciences and Technology

2 months ago

St Louis, Missouri, United States Thermo Fisher Scientific Full time
Job Description

As a key member of the Thermo Fisher Scientific team, you will have the opportunity to make a meaningful impact on a global scale. Our company is dedicated to enabling our customers to make the world healthier, cleaner, and safer.

We are seeking a highly skilled and experienced Director of Manufacturing Sciences and Technology to lead our Biologics team. In this role, you will be responsible for leading all facets of Process Validation, Technology Transfer into manufacturing, GMP floor support, and Continued Process Verification in accordance with current good manufacturing processes (cGMP).

Key Responsibilities
  • Lead the Manufacturing Science and Technology team and be responsible for process-related activities enabling Drug Substance manufacturing of Biologics.
  • Be 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.
  • Coordinates scientifically and/or technically based process improvements of clinical and commercial manufacturing processes.
  • Offers molecule stewardship and drives process lifecycle management initiatives in accordance with customer molecular strategies as needed.
  • Actively liaises with external customers and internal partners to facilitate execution of customer projects.
  • Operate as a key point of contact for Joint Steering Committees engaging with senior-level executives both internally and externally.
  • Represent the St. Louis site as a domain expert during external and internal regulatory compliance inspections.
  • Support the authoring, reviewing, and approving of regulatory applications for customers as well as support responses to regulatory agencies.
  • Build and responsibly manage 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.
  • Drive continuous improvements and establish best-in-class MSAT capabilities by improving enabling processes and systems.
Requirements
  • PhD in Biotechnology, Chemical, or Pharmaceutical Engineering, or a related field, with a minimum of 8 years of relevant experience; or
  • M.S./M.A. in Biotechnology, Chemical, or Pharmaceutical Engineering, or a related field, with a minimum of 12 years of relevant experience; or
  • B.S./B.A. in Biotechnology, Chemical, or Pharmaceutical Engineering, or a related field, with a minimum of 14 years of relevant experience.

We offer a competitive remuneration package, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.