Investigates, creates, and validates new scientific methodologies used to control raw materials, production intermediates, and final products on highly unique and complex projects. Will be involved in both clinical and post-marketing stages of drug manufacturing. 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 demonstrating a high level of technical proficiency in supporting the clients product. 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 judgement. Typically works in manufacturing technical support for both commercially active products and transfer of new products to the site. Makes decisions that frequently require developing new options to solve complex problems. Serves as a champion for continuous improvement opportunities around process optimization and operations expertise.
1. Develops scientific strategy to support site client product portfolios.
2. Leads strategic initiatives and solutions in support of assigned product portfolio. Works closely with site management to optimize requirements of both client and site for portfolio of projects. 3. Leads development and coordination of realistic proposals and timelines for project activities supporting assigned portfolio. Leads meetings/teleconferences with clients.
4. Leads development of methods and processes that meet or exceed the expectations from clients and provide innovation as necessary.
5. Leads research of industry practices and applies to innovative process optimization opportunities internally and for client products. Presents recommendations internally and to clients.
6. Drives for continuous improvement and process optimization. Provides technical support and training to operations team to ensure optimal support of assigned products.
7. Guides and advises during implementation of new methodologies and processes in support of assigned product portfolio.
8. Leads resolution of problems related to the execution of manufacturing processes.
9. Liaises with internal scientific, analytical, and laboratory functional areas to meet product support objectives.
10. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines.
11. Able to lead cross functional teams in root cause problem solving utilizing multiple methodologies to determine strong corrective and preventative actions to prevent reoccurrence of issues. 12. Provides technical recommendations to ensure plant operation within state and federal government regulatory requirements (FDA, EMEA, OSHA, EPA, IBC, etc.).
Bachelors of Science in Chemistry, Biochemistry, Biology, or related physical science.
Typically requires 12 years of progressive scientific experience, including 9 years in a related life sciences field.
If related Master's degree, typically requires 10 years of related experience.
Experience working directly with operations team and clients on product support.
Equivalent combinations of education, training, and relevant work experience may be considered.
1. 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.
2. Thorough knowledge of Good Manufacturing Practices.
3. Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint) and statistical software (Mini tab).
4. Superior critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including managing technical discussions with internal and external clients.
5. Ability to lead multiple projects simultaneously.
6. Ability to develop knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
7. Demonstrated proficiency with process improvement methodologies to drive continuous improvement and optimization of processes.
8. Thorough understanding and working knowledge to apply multiple root cause analysis methodologies to drive out process variation.
9. Must have a sound technical approach to problem solving with a high level of learning ability, plus excellent planning and organization skills.
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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.