Seegene USA
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 customer’s expectations for Seegene products.
What we offer:
- Join the fast growing team with all opportunities to build up 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 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 supervises 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 at 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 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.
