Staff R&D/Mfg Scientist

Thermo Fisher Scientific - Greenville, NC3.6

Full-time
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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.

Location

Greenville, NC

How will you make an impact?
Investigate, create, and validate new scientific methodologies used to control raw materials, production intermediates, and final products on a complex scope of projects. Mainly involved in pre-clinical and clinical stages of drug development. Work on technical/scientific project activities to execute strategies and technical solutions that meet client needs and expectations. Participate in discussions with clients with a high level of technical proficiency. Engage in creation and validation of analytical methodologies for clinical, scale up, and/or registration batches, including technology transfer and stability of projects from clients. Evaluate and contribute to the design of the tests and procedures that support the manufacturing processes and to provide problem solving as necessary with independent judgement. Make decisions that require developing new options to solve complex problems. May execute 25%-100% of their work at the bench level. Staff Scientists will create new business opportunities.

What will you do?

Participate in the development and validation of analytical methods that meet or exceed the expectations from clients and provide innovation as necessary. Develop realistic proposals and timelines.
Serve as a mentor for scientists in the laboratory regarding technical knowledge, work ethic, and attitude.
Coordinate research of industry practices and processes and apply to innovative drug development for client products.
Present recommendations internally and to clients. Lead projects without supervision; may lead multiple projects, including managing project timelines and deliverables. Represent Analytical Development in customer meetings to receive/deliver information, requests and requirements.
Prepare study reports and present data internally and externally to customers; serve as the technical lead for deviation investigation, out-of-specification or aberrant results and process changes; troubleshoot assay and instrumentation issues. This will involve data mining, trending and analysis to identify problems or determine process control.
Guide and advise during implementation of new methodologies and processes.
Liaise with internal scientific, manufacturing, and laboratory functional areas to meet project and team objectives.
Lead peer review of laboratory reports.
Attend scientific seminars and present publications.
Investigate, evaluate, and recommend the purchase of laboratory equipment.
Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines.
Maintain the necessary compliance status required by company and facility standards.
How will you get here?

Education/Experience

Bachelor of Science in Chemistry, Biochemistry, Biology, or related physical science. Advanced degree preferred.
Typically requires 8 years of progressive scientific experience (5 years in a related life sciences/pharmaceutical experience preferred).
If related Master's degree, 6 years of related experience preferred. If related PhD, 3 years of related experience preferred.
Experience working directly with clients.
Knowledge, Skills, Abilities

Expert in HPLC and GC method development, troubleshooting and validation, proficient in other related analytical instrumentation (IEF, CE, IR, KF, UV), hands-on knowledge of LC/MS and ELISA preferred. Advanced knowledge of varied aspects or a specialized aspect and working knowledge of principles and concepts in other relevant disciplines.
Excellent 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).
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.
Supervisory Requirements
None

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.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here 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.