Director, Manufacturing Sciences and Technology

at  Thermo Fisher Scientific

JOB DESCRIPTION

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. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find treatments for cancer.

REQUIREMENTS:

• 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.

KNOWLEDGE, SKILLS, ABILITIES

• 7+ years in a leadership role of 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).
• Proficiency in working with multicultural and cross-disciplinary project teams
• Good GMP knowledge
• Customer-centric mentality
• Experience in leading teams
• Excellent organization, planning, problem solving and critical thinking skills
• Excellent writing, communication and presentation skills
• Energy and drive (committed, drive for results)
• Willingness to travel up to 10%

• 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.
• Coordinates 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.
• Operate as 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 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.
• Ensure 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.