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Senior Scientist, Molecular Assay Development

  • Irvine, CA
  • $120,000/yr - $145,000/yr USD / Year

Seegene USA

As a Senior Scientist for Molecular Assay Development you'll lead the way in developing assays, analyzing results, proposing new experiments, and optimizing overall assay performance.

About the role:

You will be a leading senior member of the Assay Development team, reporting to the Assay Development Manager. You will serve as a primary laboratory technical leader, developing assays based on Seegene’s proprietary technologies and other molecular diagnostics methods, analyzing results, proposing new hypothesis and experiments and troubleshoot/optimize/improve overall assay performance. You will serve as a leader in all aspects of developing assays based on Seegene’s proprietary technologies, from literature review and in silico design to FDA-submission and manufacturing transfer. You will leverage your molecular assay development expertise by working cross-functionally to exceed customers’ expectations for Seegene products.

What we offer:

  • Join the fast-growing team with all the opportunities to build together
  • Amazing team to work with
  • Seegene pays 100% of Health insurance/Life/STD/LTD premium for the employee and 70% for dependents. Other voluntary insurance is also available.
  • Generous 401k, no vesting period, no waiting period
  • Generous vacation and corporate holidays
  • Various employee discounts and perks

Responsibilities

  • Leader in the design and development of PCR-based IVD products, from concept to commercialization including initial literature review to completed FDA clinical trials and successful transfer to manufacturing
  • Design rigorous analytical experiments and analysis required for concept, technical feasibility, design verification, validation phases and commercial of complex assays
  • Present data at regular internal and external technology meetings and be responsible for taking technical decisions to drive the project forward
  • Effectively manage experiments with shifting priorities and meet due dates
  • Create and modify critical documents, and study reports for phase gate activities and regulatory submissions
  • Create verification and validation SOPs and technical reports
  • Train new team members and supervise the team to efficiently perform day-to-day laboratory activities and ensure the achievement of critical project goals
  • Handle infectious samples and perform microbiological work on BSL-1 and BSL-2 organisms.
  • Participate in cross-functional core teams to ensure program risks (technical, regulatory, medical/scientific affairs, manufacturing and market/commercial) are identified and addressed

Minimum Qualifications

Required:

  • PhD in microbiology, molecular biology, biochemistry, clinical medical technology, laboratory sciences or other related areas and >3 years experience developing molecular diagnostics assays

OR

  • Bachelor’s / Master’s degree in microbiology, molecular biology, biochemistry, clinical medical technology, laboratory sciences, or other related areas and 8 years of hands-on experience with molecular biology or molecular diagnostics assays OR
  • 15 years of hands-on experience developing molecular assays for the IVD, FDA-regulated market

AND

  • Demonstrated experience in the development and commercialization of >1 FDA-approved molecular diagnostic assay (not including COVID assays)

Preferred

  • Led small teams focused on resolving short-term issues (troubleshooting, process improvement, etc)
  • Experience with all aspects of molecular chemistry science, including primer / probe design, enzyme selection, quality control methods, electrophoresis, and other analytical tools
  • Experience with fundamental biostatistic tools, such as MiniTab or JMP
  • Familiarity with the molecular biology of infectious diseases
  • Understanding of major molecular diagnostic test platforms, including Hologic, Roche and others
  • Demonstrated ability to focus on meeting timelines and milestones
  • Drive rigorous implementation of the scientific method to address all technical issues
  • Experience designing and optimizing nucleic acid extraction/purification
  • Experience working with various sample types such as whole blood, sputum, BAL, etc.
  • Experience designing and optimizing real-time PCR or RT-PCR reactions.
  • Applied fundamental statistical concepts in designing and interpreting experimental results
    Experience working in a BSL2 environment

Desirable Characteristics/Attributes:

  • Excellent written and communication skills
  • Attention to detail
  • Able to collaborate within multi-disciplinary teams>Mentor and champion the development of junior associates
  • Achieve goals with little supervision (weekly)

You can apply for this position via LinkedIn using the button below or by completing the application form at the bottom of this page.

Senior Scientist, Molecular Assay Development

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SeegeneUS values diversity, inclusion & belonging for all, and is proud to be an Equal employment Opportunity employer. It's important to us that our workplace empowers people of all backgrounds, identities, and experiences to feel respected, valued and able to contribute at the highest level. Self-identification is an important tool that provides an avenue for candidates to share their demographic information so that SeegeneUS can evaluate and implement strategies to build a culture that supports our community. As part of these efforts, we invite candidates to self-identify as to the categories below. Submitting this information is entirely voluntary and any information provided will be maintained confidentially and will not be used in making hiring decisions.

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