Director, Assay Development
Zymeron Corporation Zymeron Corporation Durham, NC Durham, NC Full-time Full-time $100,000 - $200,000 a year $100,000 - $200,000 a year We are seeking an experienced assay development scientific director with demonstrated expertise in nucleic acid amplification tests (NAAT), rapid molecular tests, and assay integration.
This position is an excellent opportunity for talented and motivated individuals seeking a scientific leadership role in a start-up environment developing rapid, cost-effective nucleic acid assays.
The candidate will lead the molecular assay development team, supervise junior scientists and associates, and coordinate with the device engineering and system integration team.
The ideal candidate will have a track record of developing rapid molecular assays on novel platforms and have the capability to effectively work across multiple domains of expertise and navigate complex projects.
Zymeron aims to transform diagnostic testing by developing innovative molecular assays for infectious diseases that are designed to enable accurate and reliable sample-to-result at the point of care or at home yet being low cost and rapid.
The assay and device work together to provide central laboratory-level accuracy and be operated by untrained users in any decentralized setting.
Location:
Research Triangle Park, North Carolina Job Type:
Full Time Required Experience 1) Ph.
D.
in molecular biology, biological engineering, microbiology, biochemistry, or related fields with 5
years of relevant laboratory research or product development experience.
2) Minimum 3 years' experience in an in vitro diagnostic (IVD) development environment.
3) Strong technical foundation in analytical techniques for characterizing nucleic acids.
Expert knowledge of PCR, qPCR, DNA/RNA modifying enzymes, nucleic acid biophysics and biochemistry.
4) Demonstrated expertise in developing DNA/RNA molecular assays, isothermal amplification (LAMP, RPA etc) including designing probes, primers, and enzymes.
Knowledge and experience using quantitative methods to analyze, optimize, and characterize molecular assay performance characteristics including specificity, dynamic range, precision, etc.
5) Experience with new DNA/RNA amplification reagent formulation and optimization, QC, workflow development, and assay integration.
6) Experience with product development process in NAAT and IVD space.
7) Experience developing CRISPR based diagnostic assays is a plus.
8) Strong data analysis skills with knowledge and experience with statistical tools and related software 9) Experience preparing and transferring research and development methods and reagents to engineering and manufacturing teams.
10) Familiar with IVD regulations such as CE-IVD, CLIA, and FDA US-IVD is preferred.
Experience with 21 CFR 820.
30 Quality System Regulation, Design Controls is a plus.
11) Demonstrated attention to detail.
Strong self-direction.
Description Role 1) Lead nucleic acid amplification assay development and assay verification activities.
Design assay development plans and work collaboratively with the device engineering and system integration team.
2) Mature assay technology and define assay requirements working at the interface of nucleic acid, enzyme biochemistry, and engineering to characterize DNA/RNA, molecular biology, and enzymatic reactions on rapid NAAT platforms.
3) Analyze and interpret data to troubleshoot and optimize LAMP or RPA based assay performance.
4) Design and run guard-banding studies to ensure assay robustness.
5) Lead studies to test hypotheses related to target product profiles.
Analyze data, evaluate results, form conclusions, and determine future experiments.
6) Present findings or project reviews at internal or external meetings.
Apply advanced technical writing skills to produce reports and proposals.
7) Document assay development progress with clear presentations and technical writing.
8) Coordinate technical transfer of new assays and procedures for validation and scaling up to clinical study sites and/or collaborator facilities.
9) Supervise junior scientists and associates on the development of new assay reagents and formulations.
What We Offer:
1.
Zymeron offers competitive paid leaves, vacations, flextime, health (medical, dental and vision) insurance, retirement plans, 401k matching, bonuses, stock options, and others.
2.
Zymeron participates in E-Verify Employment Verification.
3.
Zymeron is an equal opportunity employment (EOE) employer.
Job Type:
Full-time Pay:
$100,000.
00 - $200,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Flexible schedule Flexible spending account Health insurance Health savings account Life insurance Paid time off Professional development assistance Relocation assistance Retirement plan Vision insurance Schedule:
8 hour shift Supplemental pay types:
Bonus pay Education:
Doctorate (Required) Work Location:
In person 1) Lead nucleic acid amplification assay development and assay verification activities.
Design assay development plans and work collaboratively with the device engineering and system integration team.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
This position is an excellent opportunity for talented and motivated individuals seeking a scientific leadership role in a start-up environment developing rapid, cost-effective nucleic acid assays.
The candidate will lead the molecular assay development team, supervise junior scientists and associates, and coordinate with the device engineering and system integration team.
The ideal candidate will have a track record of developing rapid molecular assays on novel platforms and have the capability to effectively work across multiple domains of expertise and navigate complex projects.
Zymeron aims to transform diagnostic testing by developing innovative molecular assays for infectious diseases that are designed to enable accurate and reliable sample-to-result at the point of care or at home yet being low cost and rapid.
The assay and device work together to provide central laboratory-level accuracy and be operated by untrained users in any decentralized setting.
Location:
Research Triangle Park, North Carolina Job Type:
Full Time Required Experience 1) Ph.
D.
in molecular biology, biological engineering, microbiology, biochemistry, or related fields with 5
years of relevant laboratory research or product development experience.
2) Minimum 3 years' experience in an in vitro diagnostic (IVD) development environment.
3) Strong technical foundation in analytical techniques for characterizing nucleic acids.
Expert knowledge of PCR, qPCR, DNA/RNA modifying enzymes, nucleic acid biophysics and biochemistry.
4) Demonstrated expertise in developing DNA/RNA molecular assays, isothermal amplification (LAMP, RPA etc) including designing probes, primers, and enzymes.
Knowledge and experience using quantitative methods to analyze, optimize, and characterize molecular assay performance characteristics including specificity, dynamic range, precision, etc.
5) Experience with new DNA/RNA amplification reagent formulation and optimization, QC, workflow development, and assay integration.
6) Experience with product development process in NAAT and IVD space.
7) Experience developing CRISPR based diagnostic assays is a plus.
8) Strong data analysis skills with knowledge and experience with statistical tools and related software 9) Experience preparing and transferring research and development methods and reagents to engineering and manufacturing teams.
10) Familiar with IVD regulations such as CE-IVD, CLIA, and FDA US-IVD is preferred.
Experience with 21 CFR 820.
30 Quality System Regulation, Design Controls is a plus.
11) Demonstrated attention to detail.
Strong self-direction.
Description Role 1) Lead nucleic acid amplification assay development and assay verification activities.
Design assay development plans and work collaboratively with the device engineering and system integration team.
2) Mature assay technology and define assay requirements working at the interface of nucleic acid, enzyme biochemistry, and engineering to characterize DNA/RNA, molecular biology, and enzymatic reactions on rapid NAAT platforms.
3) Analyze and interpret data to troubleshoot and optimize LAMP or RPA based assay performance.
4) Design and run guard-banding studies to ensure assay robustness.
5) Lead studies to test hypotheses related to target product profiles.
Analyze data, evaluate results, form conclusions, and determine future experiments.
6) Present findings or project reviews at internal or external meetings.
Apply advanced technical writing skills to produce reports and proposals.
7) Document assay development progress with clear presentations and technical writing.
8) Coordinate technical transfer of new assays and procedures for validation and scaling up to clinical study sites and/or collaborator facilities.
9) Supervise junior scientists and associates on the development of new assay reagents and formulations.
What We Offer:
1.
Zymeron offers competitive paid leaves, vacations, flextime, health (medical, dental and vision) insurance, retirement plans, 401k matching, bonuses, stock options, and others.
2.
Zymeron participates in E-Verify Employment Verification.
3.
Zymeron is an equal opportunity employment (EOE) employer.
Job Type:
Full-time Pay:
$100,000.
00 - $200,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Flexible schedule Flexible spending account Health insurance Health savings account Life insurance Paid time off Professional development assistance Relocation assistance Retirement plan Vision insurance Schedule:
8 hour shift Supplemental pay types:
Bonus pay Education:
Doctorate (Required) Work Location:
In person 1) Lead nucleic acid amplification assay development and assay verification activities.
Design assay development plans and work collaboratively with the device engineering and system integration team.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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