Thermo Fisher Scientific Staff Scientist, Assay Development in Fremont, California

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.

How will you make an impact?

The Staff Scientist, Assay Development is responsible for the in-vitro diagnostics (IVD) product development, product transfer, product support and product improvement activities. The ideal candidate shall have wide range of specialized experimental techniques and skill in their application, exercise independent judgment in developing methods and techniques, strong capabilities of resolving issues in creative ways and advocating corrective action, excellent communication and interpersonal skills that cultivate collaborations for maximum efficiency.

What will you do?

  • Research, design and develop methodologies, techniques, verification/validation criteria, and manufacturing processes of new products.

  • Execute complex experiments independently and be capable of performing in-depth statistical analysis, interpreting experimental results and making sound conclusions.

  • Comply with FDA Design Control guidance and regulations.

  • Collaborate with multidisciplinary functions to develop, manufacture and market quality IVD products meeting user requirements.

  • Prepare and present technical data summaries for design review needs.

  • Write and edit technical reports, study protocols and manufacturing procedures.

  • Create product in-process and release specifications to ensure manufacturing robustness.

  • Provide product and study descriptions, data summaries and analysis, and other required information to support US premarket notification/approval, Technical File for CE and worldwide product registration and other regulatory related functions.

  • Work with all areas of the company to resolve technical issues related to product transfer, manufacturing, testing and performance.

  • Participate in efforts to exhibit a positive impact on product quality and perception of the company in the marketplace.

  • Collaborate with internal and external customers to implement new product opportunities, prioritize the project and execute the tasks with the available resources.

  • Mentor junior Scientists, Associates, Manufacturing and QC Chemists in areas of expertise while providing technical supervision to personnel in laboratory operations/projects leadership.

  • Point person to represent R&D technical manager.

  • Deliver new products or complete assignments in accordance to timeline.

  • Perform other responsibilities to support the needs of the department as assigned.

How will you get here?

  • BS or MS (Biochemistry, Biology, Immunology, Molecular Biology or other Scientific discipline) with a minimum of 8 years, or PhD with a minimum of 5 years product development experience.

  • Strong preference will be given to those candidates having hands-on laboratory-based experience in IVD assay development from concept through development to market.

  • In-depth knowledge and expertise in bio-conjugation, recombinant antibody/protein technologies, protein purification and characterization is desired.

  • Familiar with design control and regulatory requirements related to IVD products.

  • Previous experience in medical device premarket submission such as 510(k) and/or PMA is a plus.

  • Strong verbal and written communication skills.

  • Excellent organization and strong project management skills.

  • Strong interpersonal skills, highly collaborative within a multi-discipline team and contribute to a supportive and positive work environment.

  • Experience in collaborating with business, partners, customers, and/or contractor suppliers.

  • Self-motivated, independent and a proactive driving force of efficient execution.

  • Capable of multi-tasking and changing priorities caused by time, markets, customers, budget or other constraints.

  • Capable of coaching and assisting new or junior team members on approaches and methods for complex assignments.

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com at http://jobs.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.

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.