Description
When you're part of the team at Thermo Fisher Scientific, you'll do meaningful work, that makes a positive impact on a global scale! Join 80,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You'll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world's toughest challenges. This includes protecting the environment, making sure our food is safe, and helping find cures for cancer.
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 groups 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 timely, 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.
- Participate and execute on analytical and functional method validation
- Involve in real time stability studies
- Collaborate with departments across the organization to resolve technical issues.
- Prepare and present written and oral plans, protocols, and 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 handle 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, LCMS, purification, 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 go-getting, 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
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits!
Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status
