Independently develops, validates, supports, and improves advanced nucleic acid analysis technologies for clinical testing. Innovates to train, troubleshoot, and improve process efficiency and robustness in the clinical lab.
ESSENTIAL JOB FUNCTIONS:
- Responsible to independently develop, optimize, and validate PCR-based assays for determining genotype, copy number variation and other molecular characteristics of RNA or DNA, which will be used in clinical quantitative and qualitative testing in a regulated clinical lab.
- Research and suggests improvements to existing methods, procedures, and materials to improve process, data quality, and reduce costs.
- Validates new technologies, methods, and processes and demonstrates that they are effective.
- Offers novel approaches and troubleshooting to solve complex technical problems
- Reliably writes and executes well defined validation protocols, SOPs, Operating Instructions and summarizes results, conclusions, and recommendations into concise technical reports.
- Uses statistical analysis to evaluate results, synthesize conclusions, and communicate recommendations.
- Provides technical and theoretical support to testing staff within area of specialty.
- Responds to support requests by working with lab staff to identify the issues, drawing on expertise to investigate root cause, and implementing and documenting solutions.
- May assist with other laboratory operations from a Senior Individual Contributor role such as inventory management, materials and supplies, general operations, and project management.
- Trains staff in scientific method and testing technologies
- Employs high level technical expertise to develop new techniques and creatively solve problems
- Interacts with management and project teams to understand the project scope and leads collaboration on complex and detailed plans and reports.
- Completes other duties as assigned by supervisor.
- A bachelor degree with 9 years PCR/molecular biology related industrial experience, a master degree with 5 years of experience or a Ph.D. degree with 3 years experience.
- Detailed knowledge of PCR assay development and validation at a clinical level with a minimum of 3 years proven experience in PCR assay development and validation is required.
- Strong understanding of and experience with laboratory equipment and liquid handling and lab automation.
- Ability to customize or configure laboratory equipment to optimize
- Familiarity with regulatory guidance (CAP, FDA) on analytical testing and clinical molecular biology lab working experience is highly desired.
- Strong understanding of experimental design, metrics, and data analysis methods to assess the production process.
- Demonstrated ability to understand and apply complex technical concepts to assay development methodology and process development.
- Detail oriented and strong written and verbal communication skills.
- Experience with statistics, process analysis, or DOE are a plus
- Ability to work independently, within prescribed guidelines, and as a team member.
- Ability to follow detailed directions in a laboratory environment.
- Strong understanding of and practical experience with nucleic acids analysis methods including extraction, sequencing, PCR, and DNA genotyping.
- Hands on experience hands on work in assay development and lab automation is highly desired.
- Experience forming, managing and leading project teams is highly desired.
- Knowledge of and experience with specific nucleic acid analytical methods such as DNA sequencing, real-time PCR, and microarray analysis are a plus.
- Ability to work independently, within prescribed guidelines, or as a team member.
- Must be familiar with Microsoft Office applications.
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