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Thermo Fisher Scientific QC Scientist II, BioAnalytical in Lexington, Massachusetts

Job Title: QC Scientist II, Bio-Analytical

When you are part of the team at 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. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Location/Division Specific Information

Viral Vector Services (VVS) at the Lexington, MA Facility

How will you make an impact?

You will work in the GMP compliant QC Laboratories to qualify and conduct bio-analytical assays that support quality control of gene therapy/viral vector bio-pharmaceutical products being developed and manufactured. You will be involved in tech transfer with clients and method validations and also contribute to the compliance and regulatory audit readiness of the lab.

What will you do?

*Applies knowledge and in-depth understanding of bio-analytical techniques on Tech-Transfer assignments. Resolves technical and tactical operations problems, communicates to stakeholders in a timely manner.

*Responsible for writing technical reports and methods validations.

*Perform routine testing of analytical methods qPCR, ddPCR, SDS-PAGE, plate-based assays, pH, osmolality, Appearance etc.

*Support the QC stability program

*Trian and oversee junior analysis.

*Must be proactive, action oriented and wiling to adapt to a change in a dynamic work environment.

*Meet sample testing deadlines and client service level agreements.

*Plenty of opportunities to learn new technologies/methods and troubleshoot/standardize existing methods.

*Ensures method performance and sample data trending is kept up to date. Significant laboratory documentation, review and revision in compliance with the regulatory standards

*Maintains cGMP compliance and audit readiness of the lab

*Generates, revises, and/or approves SOP or test methods.

*Ensures all training requirements and metrics are completed and up to date.

*Maintains a safe working environment in the laboratory and participates in safety and Supports regulatory inspections and audits

Knowledge, Skills, Abilities

*In-depth understanding of PCR methods, SDS-PAGE, plate-based assays, pH, osmolality, Appearance.

  • Experience with electronic systems such as LIMS, Trackwise and working knowledge in Excel data analysis.

*Writing technical docs and SOPs

*Experience in setting up GMP labs, oversee junior analysis.

*Demonstrated problem solving ability, interpersonal, oral and written communication skills

*Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail

*Contribute to a team based, collaborative environment promoting candor, clarity of purpose and high commitment to business goals.

Education

B.S. with 5-7 years of experience required in Molecular Biology, Biology, Biochemistry or other related scientific discipline.

Advanced degree preferred and will be considered in place of some experience; e.g. M.S. with 3-4 years experience, or PhD with 0-2 year of experience

Experience

Preferred work experience in regulated cGMP labs.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 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 and Patheon. For more information, please visit www.thermofisher.com

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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