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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.

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