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Thermo Fisher Scientific Manager, Research & Development in Greenville, North Carolina

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the drug supply chain or making sure our medicines are safe, efficacious, and of impeccable quality. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Division Specific Information:

We operate the world’s largest Pharma Services business, offering drug substance, drug development, clinical trials and drug product solutions to companies of all sizes. We help customers get high-quality medicines to patients faster. We are experts at simplifying the supply chain, can help solve complex manufacturing challenges and shorten development timelines.

Summary:

This role provides leadership within the Pharmaceutical Development Services division (PDS), specifically in the Analytical Development (AD) department. Ensures that all activities in the group are performed according to a set schedule and in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (GMP) and corporate quality standards. This is a people leadership role and the successful candidate will manage a team or teams of scientists.

How will you make an impact?

Investigate, create, develop and validate new scientific methodologies used to control raw materials, production intermediates, active pharmaceutical ingredients, bulk drug substances and final products on a complex scope of clinical stage drug development programs. You will be mainly involved in pre-clinical and clinical stages of drug development. The Manager works on technical/scientific project activities to execute strategies and technical solutions that meet client needs and expectations. The Manager will lead discussions with clients with a high level of technical proficiency and lead team(s) of scientists that develop and validate analytical methodologies for clinical, scale up, and/or registration batches, including technology transfer and stability of projects from clients.

What will you do?

  • Leads a team to develop and validate analytical methods that meet or exceed the expectations from clients and provide innovation as necessary. Develops realistic proposals and timelines.

  • Serves as a leader and mentor for scientists in the laboratory regarding technical knowledge, work ethic, and attitude.

  • Coordinates research of industry practices and processes and applies to innovative drug development for client products.

  • Presents recommendations internally and to clients. Leads a team of scientists; may lead multiple projects, including managing project timelines and deliverables. Represents Analytical Development in customer meetings to receive/deliver information, requests and requirements.

  • Ensures that all deviation investigation, out-of-specification or aberrant results and process changes; troubleshooting of assays and instrumentation issues are completed in a timely manner.

  • Guides and advises during implementation of new methodologies and processes.

  • Liaises with internal scientific, manufacturing, quality, and laboratory functional areas to ensure business processes are efficient.

  • Investigates, evaluates, and recommends the purchase of laboratory equipment.

  • Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines.

Knowledge, Skills, Abilities:

  • Proven excellence in the understanding and application of analytical chemistry for meeting product development challenges.

  • Experience managing groups of graduates in the development of analytical procedures.

  • Proven ability to train team members to handle analytical development projects within agreed timelines.

  • Ability to apply operational excellence principles within a development environment.

  • Well organized, detail oriented and able to prioritize multiple tasks.

  • Excellent working knowledge of Good Manufacturing Practices.

  • Proficiency in the English Language.

  • Demonstrated commitment to our fundamental principles of Integrity, Intensity, Innovation, Involvement, Respect and Excellence.

  • Maintains the necessary compliance status required by company and facility standards.

  • Demonstrated expertise in optimizing and qualifying analytical methods (HPLC/UPLC).

  • Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.

  • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).

  • Excellent critical and logical thinking skills.

  • Effective written, interpersonal, and presentation skills, including managing technical discussions with internal and external clients. Ability to work on multiple projects simultaneously.

  • Ability to develop knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.

  • Ability to keep current with scientific literature and industry trends relating to process technologies. Ability to develop technical solutions.

How will you get there?

Education/Experience

  • Bachelor of Science in Chemistry, Biochemistry, Biology, or related physical science. Advanced degree preferred.

  • Typically requires 12 years of progressive scientific experience (9 years in a related life sciences field, pharmaceutical experience preferred). Minimum of 5 years of management experience preferred.

  • If related Master's degree, 10 years of related experience preferred.

  • If related PhD, 6 years of experience preferred.

  • Experience working directly with clients.

Equivalency :

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

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination enough 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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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.

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