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Thermo Fisher Scientific QC Scientist II in Bedford, Massachusetts

Job Title: Scientist II

When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing out Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How will you make an impact?

Within the Quality organization of the Bedford, MA facility, we are seeking a career-conscious multidisciplinary Scientist II for an exciting opportunity to be a part of an analytical team for a fast-growing business.

This position will report to the Manager of Quality team. The ideal candidate will be a proven Scientist with experience in method development and validation, bringing strong study design and chromatography expertise to enhance our Quality team.

What will you do?

  • Conduct sustainability projects such as method crossover validation, real-time stability, and continuous improvement.

  • Collaborate with other teams to coordinate method transfer activities for New Product Introduction (NPI).

  • Review analytical procedures and provide improvement initiatives for Quality related process/procedures/documents such as, but not limited to, standard lab practices, Quality Procedures and SOPs, analytical test methods and electronic data integrity.

  • Act as a chromatography and HPLC subject Matter Expert for the quality team.

  • Maintain detailed records of all work carried out and report out in a clear, timely manner, prepare reports and presentations.

  • Perform statistical analysis on tracking data to support the site.

  • Provide support for quality related issues and coordinate resolutions.

  • Maintaining and troubleshooting laboratory equipment and instrumentation as needed.

  • Work independently and as part of a team.

How will you get here?

Education/Experience

  • BS in Chemistry or related discipline with at least 3 years of experience in Analytical chemistry, molecular biology assays and/or HPLC

  • The ideal candidate must have strong relevant technical background desired, Associate degree from accredited college/university.

  • Experience to independently plan and execute experiments, data analysis and interpretation.

  • Experience with Protein purification, Genetic Analyzers, ion-exchange Chromatography is a plus.

Knowledge, Skills, Abilities

  • Knowledge of analytical chemistry, analytical instrument qualification and Chromatography.

  • Statistical data analysis (Minitab, JMP)

  • Ability to apply knowledge and experience to new areas of Quality.

  • Experience with instrumental analysis including analytical HPLC, spectroscopy, ELISA, Protein Characterization or a combination thereof. Experience with additional techniques is a plus.

  • Strong attention to details and analytical and critical thinking skills

  • Experience working in a team, sharing data, problem solving and collaborating

  • Knowledge of current Good Manufacturing Practices (cGMP)

  • Good understanding of ISO 13485 requirements including CAPA, Risk Assessments, Deviation Investigation and Change Control process.

  • Flexibility to adapt to a dynamic environment and lead activities to meet the needs of the business while maintaining a focus on quality.

  • Excellent inter-personal, communication and organizational skills with good attention to details.

  • Versed in continual process improvement practices such as Kaizens, Gemba, 3P, 5S, Standard Work and others. Basic understanding is required

  • Ability to produce and present original technical communication materials for internal and external audiences

  • Ability to “think outside the box” to solve problems quickly

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

For more information, please visit www.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.

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