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Scientist II, Manufacturing Science

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

Job Description:

Job Description

When you are part of the team at Thermo Fisher Scientific, you will do important work, and you will be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.

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 products that are used in both research and clinical applications and provide support for continuous improvement activities.

What will you do?

* Support NPI projects and drive implementation and training for new processes and products to Manufacturing * Collaborate with R&D and operations functions to ensure on-time, robust, and cost-effective transfer of new products/QC methods into Manufacturing. * Responsible for pilot-manufacturing of new formulations/reagents including oligos for R&D. * Collaborate with departments across the organization to resolve technical issues. * Prepare and present written and oral reports to manager and project team members. * 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 3-5 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. * Familiar with automated instrumentation and laboratory analytical devices. * Experience with PLM software * Proficiency in MS Office

Knowledge, Skills, Abilities

* Strong knowledge and understanding of basic laboratory instrument. * Good understanding of data quality concepts and processes * 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 * Excellent written and verbal communication skills * EVAMOPS2020 *GTSDouble

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

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