Thermo Fisher Scientific Staff R&D/Manufacturing Scientist - Steriles Commercial in Greenville, North Carolina
Staff R&D / Mfg. Scientist – Steriles Commercial
Provides dedicated customer support in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. Investigates, creates, and validates new scientific methodologies used to control raw materials, production intermediates, and final products on highly unique and complex projects. May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development. Assists in the creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. 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. Evaluates and contributes to the design of manufacturing processes and supports problem solving as necessary with leadership and independent judgment.
Leads and writes deviation investigations to identify the root causes of departures from standards and to assess product impact.
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 a team over multiple projects; manages team's project timelines and deliverables; may review group's financials. Guides and advises during implementation of new methodologies and processes. Leads resolution of problems related to the conduct of chemical experiments. Liaises with internal scientific, analytical, and laboratory functional areas to meet project and team objectives. 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.
Bachelors of Science in Chemistry, Biochemistry, Biology, or related physical science. PhD degree preferred.
Typically requires 12 years of progressive scientific experience, preferable in life sciences.
If related Master's degree, typically requires 10 years of related experience.
If related PhD, typically requires 6 experience.
Experience working directly with clients.
Equivalent combinations of education, training, and relevant work experience may be considered.
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.
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.