Seegene USA
As the Senior Manager of Molecular Assay Development, you'll be responsible for taking IVD products from concept to commercialization, including FDA clinical trials and successful transfer to manufacturing.
About the role:
You will be a key member and leader of the Assay Development team, reporting to the SVP R&D. 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 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
- Lead 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
- Lead a team of up to four associates
- Ensure all regulatory and other documentation is complete
- 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 >5 years of 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 10 years of hands-on experience with molecular biology or molecular diagnostics assays
AND
- Demonstrated experience in the development and commercialization of >1 FDA-approved molecular diagnostic assay (not including COVID assays)
Preferred
- Managed team of >2 associates
- Working knowledge of biostatistics and tools such as MiniTab or JMP
- Understanding of major molecular diagnostic test platforms, including Hologic, Roche and others
- Experience in molecular biology techniques such as Cell culture, Flow cytometry, Microscopy, immunoassays, plasmid amplification, virus production, PCR, qPCR, NGS, library preparation, sequencing and analysis of single-cell RNA-seq data, generation of sequencing data and/or bioinformatic analysis.
Desirable Characteristics/Attributes:
- Drive rigorous implementation of the scientific method in all areas
- Mentor and champion the development of junior associates
- Excellent written and communication skills
- Achieve goals with little supervision (monthly)
- Self-starter, energizing, results-oriented, and able to multi-task
- Familiarity with the molecular biology of infectious diseases
You can apply for this position via LinkedIn using the button below or by completing the application form at the bottom of this page.
