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Scientist III, Manufacturing Science

Company: Thermo Fisher Scientific Inc.
Location: Pleasanton
Posted on: May 3, 2021

Job Description:

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 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

Pleasanton, CA, U.S.A.

How will you make an impact?

As part of the Operations team within the Genetic Sciences Division (GSD) of Thermo Fisher Scientific, the successful candidate will help support the new Genetic Testing Solution (GTS) Technical Transfer group in providing scaled molecular testing solutions into the clinical diagnostics and boarder markets. The individual will work with cross functional teams to ensure new products are designed for manufacturability and help develop and commercialize molecular assay products for both research and clinical applications and provide support for continuous improvement activities.

What will you do?

* Plans and executes development experiments, from proof of concept to validation, regulatory submission, and launch * Develop and optimize oligos and reagent formulation * Validate and transfer analytical QC test methods and specifications * Draft verification/validation protocols and reports and other documentations under design control to ensure quality development * Help manage and execute on assay stability studies * Collaborate with R&D, QA, QC, and operations functions to ensure on-time, robust, and cost-effective transfer of new products/QC methods into Manufacturing * Collaborate with departments across the organization to resolve technical issues * Actively participate as a member of cross-functional new product development teams to ensure compliance with design controls per ISO 13485 and other regulatory requirements * Work with minimal supervision and manage time effectively * Identify and communicate risks to project deadlines in advance * Perform other responsibilities to support the needs of the department, as assigned

How will you get here?

Education

* BS required /MS preferred in a science related field and 5+ years of laboratory experiences, preferably in a pharmaceutical, biotechnology, healthcare, research, or academic environment

Experience

* Experience with ISO 9001, ISO 13485, and/or GMP environments * Experience in manufacturing, product transfer, or product support functions * Hands on experience in genetic analysis tools, workflows, and chemistry in at least one of these areas: qPCR, assay formulation, oligos, microarray, sample prep * Strong bench skill and experimental design * Familiar with automated instrumentation and laboratory analytical devices. * Design Control & Change control, and experience writing design quality records * Expertise in Process Capability / Six Sigma * Experience with statistical software/tools (JMP, Minitab) for data analysis * Experience with PLM software * Proficiency in MS Office

Knowledge, Skills, Abilities

* Strong understanding of data quality concepts and processes * Ability to design DOE studies, gage R&R study, JMP, and conduct appropriate data analysis * Highly organize, strong attention to detail, and high regards for quality * Skilled at prioritization and multi-tasking in a self-driven, performance/results oriented, fast paced matrixed environment * Must be highly collaborative: enjoys working in a diverse team and contributes to a positive work environment * Be able to acknowledge sense of urgency and adapt to organizational change * Demonstrates passion for problem solving and outside-the-box thinking * Excellent written and verbal communication skills

Keywords: Thermo Fisher Scientific Inc., Pleasanton , Scientist III, Manufacturing Science, Other , Pleasanton, California

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