Thermo Fisher Scientific Steriles Project Technical Support Lead - R&D/MFG Scientist III in Greenville, North Carolina

Job Description

Summary:

Investigates, develops, and implements processes and provides technical leadership for new production intermediates and final products on highly unique and complex projects. Works on significant technical/scientific project activities to execute strategies and technical solutions that meet client needs and expectations through broad expertise. Participates in technical discussions with clients with a high level of technical proficiency. Engages in creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. Evaluates and contributes to the design of manufacturing processes and supports problem solving as necessary with leadership and independent judgment. Typically works in a specific scientific area, process validation, formulations, and/or manufacturing technical support. Makes decisions that frequently require developing new options to solve complex problems.

Essential Functions:

Interacts with top company leaders to develop scientific strategy. Leads strategic initiatives and solutions. Works closely with site management to optimize requirements of both client and site for portfolio of projects. Leads development and coordination of realistic proposals and timelines. Leads meetings/teleconferences with clients. Leads development of methods and processes that meet or exceed the expectations from clients and provide innovation as necessary. Leads research of industry practices and processes and applies to innovative drug development internally and for client products. Presents recommendations internally and to clients. Leads multiple projects; manages project timelines and deliverables. Guides and advises during implementation of new methodologies and processes. Leads resolution of problems related to the equipment and process concerns. Liaises with internal engineering analytical, and operations functional areas to meet project and team objectives. At early stages of project life, will support the development of facility design, user requirements, equipment specifications, area qualifications, and FAT/SAT activities. Travel to client and vendor locations required to support project design and implementation. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.

Education:

Bachelors of Science in Chemistry, Biochemistry, Biology, related physical science, or Engineering.

Experience:

Typically requires 8 years of progressive scientific experience, including 5 years in a related life sciences field. If related Master's degree, typically requires 6 years of related experience. If related PhD, typically requires 3 experience. Experience working directly with clients.

Equivalency :

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Advanced knowledge of principles, concepts, and practices of various aspects of a specific discipline and growing knowledge of principles and concepts in other relevant disciplines. Expert knowledge of scientific methodology and development as related to the pharmaceutical industry. Thorough knowledge of Good Manufacturing Practices. Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Superior critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including managing technical discussions with internal and external clients. Ability to lead multiple projects simultaneously. Ability to develop knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures. Ability to maintain expert knowledge and to keep current with scientific literature and industry trends relating to process technologies. Ability to develop technical solutions.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.

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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.