Thermo Fisher Scientific Director, Operations in St. Louis, Missouri
Leads all manufacturing plant operations including manufacturing support services for biopharmaceutical products including all site GMP manufacturing (including all upstream and downstream aspects of clinical and commercial manufacturing). This position will also provide matrixed/indirect leadership to quality control and technical operations teams.
Provides leadership to assigned staff by performing the following:leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best. Ensures safe, quality, and timely manufacture, testing, and supply of biopharmaceutical APIs for pre-clinical, clinical and commercial use Ensures that all production operations are controlled and executed within GMP regulatory guidelines. Provides for the identification and development of talent both within the team and across the site. Plans operations such that each project delivery is optimal, meeting the financial needs of the company while prioritizing the needs of customers and end users. Ensures the availability of appropriate SOPs and documentation are provided to enable timely GMP batch record release Provides guidance, leadership and coordination for other on-site functions in support of the plant.This includes: Safety, Quality, Human Resources, Information Technology, and Supply Chain.
Participates in establishing strategic plans and objectives, making recommendations on administrative or operational matters and ensuring effective achievement of objectives.
Directs the activities of a broad functional area; has overall control of planning, budgeting and implementing changes to methods required to run a safe and effective manufacturing operation.
- BS in biological science or engineering discipline
10 years’ experience of managing biomanufacturing operations in a highly regulated environment.
10 years’ experience of operating multi-product biomanufacturing facilities to produce clinical and commercial APIs
10 years’ experience of leading teams
Experience of biopharmaceutical drug development (>25 products),biopharmaceutical product launches (>3 launches) and commercial manufacture of Biologics API (>3 products)
- Equivalent combinations of education, training, and relevant work experience may be considered.
Ability to drive safety, quality, functional, technical and operational excellence in the disciplined manner required of a GMP facility.
Ability to inspire and foster innovation, collaboration, tranparency and team effectiveness.
Ability to drive Customer Experience and a Commitment to Excellence.
Effective written, interpersonal, and presentation skills.
Ability to work on multiple projects simultaneously
Expert knowledge of mammalian cell culture products
Leadership of people in multi-disciplinary technical and scientific teams
Expert knowledge of regulatory guidelines: EU, US, Australian, ICH, etc.
Ability to travel up to 20%
Excellent MS Office skills
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.