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Thermo Fisher Scientific Inc.

Manager CTM Manufacturing PDS

Thermo Fisher Scientific Inc. - Greenville, NC

Job Description

Manager of Clinical Trials Manufacturing Operations

Summary:

The Manager of Clinical Trials Manufacturing Operations (CTMO) plans, manages, leads, and controls the activities necessary to produce solid/semi-solid or liquid dose products that: meet quality specifications; comply with the regulatory and customer requirements; produced at optimum production costs; supervisory and operative staff are well trained; and meet customer demands in a timely fashion.

Essential Functions:

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.

Manages staff (operatives, maintenance, mechanics, etc.) ensuring that these groups are adequately trained, motivated, and developed and that responsibility and accountability are assigned at the proper levels.

Works with existing customers and new potential customers to execute the strategic plan and grow the business.

Ensures that all unit indicators support the company’s objectives and that favorable results are being achieved or appropriate actions is being taken. Ensures that all operations are performed in the most economical manner practical.

Budgets and ensures that the division has adequate resources in facilities, equipment, and personnel to produce the customer demand. Establishes direction for the department by developing goals that support O&T and company goals and strategies.

Ensures that all operations are validated and fully comply with all Current Good Manufacturing Practices (cGMP’s). Responsible for area compliance in the face of FDA, QAT, and OSHA inspections.

Establishes / approves the technical requirements for production documentation including equipment and systems specifications, manufacturing formulas, POMS procedures, filling and packaging work orders, Standard Operating Procedures (SOP’s), Environmental Procedures, PM’s, etc.

Uses input from Operations Planning, plans, schedules, and executes production workload to ensure product availability when demanded, while maintaining product inventory at its lowest level.

Ensures that all products and drugs are available at point of demand in sufficient quantities to prevent product backorders. Ensures equipment and facilities are adequately maintained through effective P. M. and facility upgrade programs.

Works in a safe manner in order to create an injury-free and incident-free workplace.

Complies with all job-related safety and other training requirements.

Performs other duties as assigned.

Job Scope:

Provides tactical direction and immediate supervision to a group of employees by assigning tasks, checking work, and maintaining schedules. Erroneous decisions or failure to achieve results will add to costs and may impact the short term goals of the company.

Supervision:

Manages the coordination of the activities of a section or department with responsibility for results.

Qualifications:

-Bachelor’s degree in Engineering, Chemistry, Microbiology, Pharmacy or related science required

-5 years of relevant experience in pharmaceutical manufacturing of steriles

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.

20 days 12 hours ago

Thermo Fisher Scientific Inc.

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Manager CTM Manufacturing PDS Thermo Fisher Scientific Inc. - Greenville, NC, United States

   

Location: Greenville, NC

Company Profile:
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Thermo Scientific, Life Technologies, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.