Staff Scientist, Molecular Biology

This role supports the new Rapid Diagnostics Solutions (RDS) business unit in San Diego, California, part of the group of diagnostics businesses at Thermo Fisher Scientific. We are focused on increasing access to affordable innovations in diagnostic testing and enabling data-driven decisions. What we do matters because our work has a direct impact on people's lives, and we take that responsibility seriously.
Position Summary:
Mesa Biotech, part of Thermo Fisher is a fast growing, ISO certified, FDA-cleared, medical device company that has achieved a dramatic simplification in the complexity of DNA and RNA molecular testing. Our patented technology provides everything needed to conduct rapid molecular tests at the point-of-care. The palm-sized, reusable dock and disposable test cassette form a user-friendly system for use anywhere, from the physician's office to other patient care settings.
We are seeking a Staff Scientist, Molecular Biology to actively participate and support the development of point-of-care molecular diagnostic kits in a demanding, fast-paced environment. You will work independently and closely with other scientists to design and develop multiplexed PCR based tests for a point-of-care instrument.
The Staff Scientist, Molecular Biology has in-depth understanding of company goals and will work to develop point-of-care molecular diagnostic assay products. Daily activities include: Feasibility experimentation, composition of SOP documents and product transfer into manufacturing, verification and validation testing, and on-going support of transferred products.
Key Responsibilities:
- Develop innovative and creative approaches based on interpretation and analysis
- Design moderate to complex experiments for PCR assay and Real time PCR quantification method development
- Work with BSL-2 pathogens and human specimens including whole blood, urine, respiratory specimens and implement molecular biology laboratory and microbiology workflows and RNase-free handling
- Develop and optimize lateral flow strip chemistry that is required for detection of post-amplification materials and result interpretation
- Works with Supervisors and Managers across the organization to effectively obtain and allocate resources to complete programs and projects on time
- Uses strong relationships to identify gaps, challenges, and potential opportunities
- Ability to write and maintain standard operating procedures (SOPs), manufacturing instructions, quality control test methods, and experience with document control procedures
- Conduct product scale-up and transfer into manufacturing, with any required support troubleshooting
- Conduct verification and validation testing using clinical samples and contrived viral samples
- Ability to lead projects and supervise a small team of other scientists, associate scientists, technicians, etc.
Minimum Requirements/Qualifications:
- At least 5 years of post-doctoral laboratory experience in product development, or B.S. degree in Molecular Biology, Biology or Biochemistry with a minimum of 10 years relevant industry experience, preferably experienced working under Design Control
- Proven experience developing RT-PCR based in vitro diagnostic assays from concept through technical transfer and commercial launch
Personal attributes:
- Have excellent presentation skills
- Strong writing skills, able to maintain laboratory notebook
- Be able to work with internal and external team members
- Excellent laboratory skills
- Able to solve problems of a complex nature
- Effectively communicate results and development updates to management through meetings and reports
Non-Negotiable Hiring Criteria:
- At least 5 years of post-doctoral assay development experience, or B.S. degree in Molecular Biology, Biology or Biochemistry with a minimum of 10 years relevant industry experience
- Proven experience developing RT-PCR based assays from concept through technical transfer and commercial launch
- Deep understanding of technical concepts of RT-PCR assay development
- Mentor and 'lead by example' for R&D and assay development project team members
- Ability to work independently
- Work within an integrated multidisciplinary laboratory and be able to work with other scientists, technicians, and engineers
- Interact and work effectively with a demanding, fast-paced biotech startup environment
- Ability to work long hours and execute under pressure with short turnaround times
- Ability to speak, write, and use all office equipment including scanner and printer, phone, computer, etc.
- Available nights, weekends, and holidays when needed
Ability to lift
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.