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.
Location/Division Specific Information:
- South San Francisco, Ca.
- Genetic Testing Solutions
How will you make an impact?
A contributing member of the GTS group who will work as part of a dynamic team of R&D, program management, manufacturing, and business development professionals to execute on strategic development projects. They will work closely with project teams to execute planning and testing on EUA and IVD product submissions. Thus, the individual will be expected to exercise influence across functional teams and provide input to management on strategic decisions.
What will you do?
- Support large or multiple development projects, aligning test strategies with regulatory strategy and meeting project objectives.
- Lead test method and strategy design, protocol execution, data analysis, and communication to stakeholders and project team members.
- Design and conduct scientific or engineering experiments using laboratory equipment and calculations.
- Create new or optimize existing laboratory procedures and test methods.
- Plan the use of equipment, materials, and own time.
- Generate project documents including, test plans, protocols, and reports.
- Maintain complete and thorough project records and training file in accordance with division standard. Comply with all company safety regulations and procedures.
- Work cross-functionally in a group setting to ensure that project milestones and goals are achieved.
- May be required to perform other related duties as required and/or assigned.
How will you get here?
- A degree in the field of Bioengineering, Chemistry, Molecular Biology, or a related field with a minimum of 5 years’ experience in product development for research, clinical, medical device or other relevant industry.An interdisciplinary education and/or experience is preferred to allow for a systems-level approach on projects.
- Experience with qPCR techniques and nucleic acid extraction methods, as well as knowledge of instrumentation and genetic analysis applications.
- Ability to quickly grasp the functionality and interdependencies of complex multidisciplinary systems, to include lasers, optics, fluidics, electro-mechanical devices, software, algorithms, biological samples, and biochemistry.
- Proven ability to execute complex experiments independently, perform statistical analysis (the calculation of sample sizes and/or estimation of statistical power), interpret experimental results, and make sound conclusions
- Ability to understand the broader impact of design features, testing methods, and test results to the user, customer, regulator, and to the marketability of the product
- Experience working within a regulated medical device industry.
- Good written and oral communication skills.
- Experience creating documentation to meet regulatory and quality requirements for product development.
- Greets challenge and change as opportunity.
- Must be flexible and comfortable working in a fast-paced environment.
- Strong interpersonal skills with an ability to collaborate with others in a multi-disciplinary team setting.
Preferred Qualifications (nice to have)
- Experience with JMP data analysis, programming Excel macros, or other related programs a plus.
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 EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.