Director, MSAT

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

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.

Location/Division: St. Louis, Missouri, Onsite PSG - Biologics

How will you make an impact:

The Manufacturing Sciences and Technology (MSAT) Director is 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). They will have a strong leadership and scientific mentorship to the MSAT team to ensure robust and reliable production processes are established through a meticulous technology transfer process to enable the site to meet and/or exceed client delivery commitments.

In Biologics at Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative large molecule therapies. Placed in the forefront of our leading and groundbreaking businesses enabling clients to change lives with therapeutics for often unmet needs. This role will drive the planning, execution and customer interaction for the MSAT function during technology transfer from process development through to Commercial manufacturing.

They will be accountable for all aspects of implementing, validating and monitoring robust and efficient manufacturing processes to produce human clinical trial and commercial products.

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.

* 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 guide 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 lead 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.

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).

* Proficiency in working with multicultural and cross-disciplinary project teams.

* Good GMP knowledge.

* A customer-centric…