QC Senior Scientist

Job Description

QC Senior Scientist

When you're part of Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. We’re at the heart of the global response to COVID-19 – particularly in analysis of the virus, diagnosis and personal protection. Your work will have real-world impact!

Location/Division Specific Information

This position supports the QC Analytical team for our Biologics Division in St. Louis, MO. As part of the Quality Control team, you directly impact patients’ lives by providing testing to ensure their biologic pharmaceuticals are safe and potent.

How will you make an impact?

The QC Senior Scientist will participate in the day to day operations related to supporting and resolving technical issues as a Subject Matter Expert within Quality Control Department. The incumbent is responsible for following Current Good Manufacturing Practices (cGMP). The focus of the position will be to ensure supporting Method Validation and Transfer documentation activities, supporting OOS investigations, and communicating to customers regarding QC deliverables. This person will interact in a positive manner on quality-related issues internally and externally.

What you will you do.

• Drives t troubleshooting, technical discussions, teleconferences, and client visits for technical QC Investigations.
• Qualification/Establishment: leads the successful transfer of QC methods and communicate in scientific discussions with the technical teams.
• Perform technical support for QC OOS/OOT investigations and Deviations. This could include but not limited to: documenting investigations within Trackwise, identifying root cause and appropriate CAPA’s, supporting manufacturing investigations as required.
• Serves as a Technical QC SME for Regulatory and Client audits and inspections.
• Creates collaboration between internal and client teams to complete QC projects, process solutions, and/or process improvements.
• Coordinate and connect with Program Managers and clients for project related needs and issues. Provides risk mitigation strategies to ensure completion of QC activities.
• Document and/or revise SOP’s, Test Methods, Specification Documents, Protocols, Reports, or other Quality records as required.
• Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA.

How will you get here?

Education

Minimum of a Bachelor’s Degree in a Biological Science related field and 8+ years related experience in biopharmaceutical or pharmaceutical industry OR a Master’s Degree and 6+ years industry experience.

Experience

Strong understanding of scientific principles for wide range of analytical techniques (HPLC, ELISA, Cell-Based Assay, Capillary Electrophoresis, etc.) is required. Advanced knowledge of FDA guidance for industry for Analytical Procedures and Methods Validation for Drugs and Biologics

Knowledge, Skills, Abilities

• Ability to understand customer requirements related to Quality control, including processes and equipment.
• Outstanding technical writing skills.
• Strong interpersonal skills including actively listening, conflict resolution and the ability to effectively influence diverse customers for positive outcome.
• Ability to build positive relationships with client while instilling trust and confidence
• Highly organized with attention to detail, excellent interpersonal skills
• Familiar with standard project management concepts, tools and responsibilities (objectives, scope, deliverables)
• Proven understanding of cGMPs and Quality Control regulatory requirements. Experience with authoring quality documents for QC assay validations.
• Routine use of MS Excel, MS PowerPoint, and MS Word is essential

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. Please contact us to request accommodation.