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?
* 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 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 *