This posting is for a research and development scientist for the Pfizer Clinical Pharmacogenomics (PGx) Laboratory. This position is responsible for the assay development of nucleic acid tests as well as running those assays in a CLIA regulated environment. The position is also responsible for direct communication with the laboratory users, such as clinical and research teams. The selected applicant will be responsible for the development of high complexity CLIA LDTs in a fast paced environment for both clinical and research programs. The position will allow for growth of the selected candidate in both assay development, regulatory work, and biomarker assays integral for clinical drug development. In addition the applicant will be responsible for the assessment and incorporation of Next Generation Sequencing technology into the PGx laboratory. This will include the establishment of assays, SOPs and bioinformatics pipelines for data delivery back to clinical and research units.
The selected applicant will be involved in new technologies and assay evaluation and development.
- Follow the lab procedures for specimen handling, test analysis, reporting, and maintaining records of patient test results.
- RNA assay development for biomarker research in clinical and research projects.
- Establishment of NGS assays for DNA/RNA Seq
- Establishment of NGS bioinformatics pipelines for data analysis and storage
- Assist in drug development by returning results necessary for drug filing and enrollment in clinical trials.
- Perform clinical and research testing in a CLIA regulated environment, meeting all applicable state and federal guidelines.
- Perform proficiency testing following all relevant laboratory SOPs.
- Follow the lab quality control and quality assurance policies and keep documentation using multiple information management systems.
- Work with LIMs to track samples and data generated by the PGx Laboratory.
- Identify and report problems that may affect test performance, results, and final reports; solve these problems under the supervision of lab supervisor or director.
- PhD in human genetics, genomics, or molecular biology preferred, or a Master’s degree with 6-8 years of experience.
- 5+ years of working in a high complexity molecular biology or genetics laboratory dealing with patient and/or research samples.
- Familiarity with laboratory automation and high throughput platforms.
- Experience with NGS systems and assay design for targeted DNA sequencing, targeted RNA Seq and whole transcriptome RNA Seq.
- Experience with bioinformatics pipelines for NGS DNA/RNA data sets.
- In depth knowledge of RNA expression analysis including, but not limited to, TLDA, TaqMan, RNA Seq.
- Comprehensive understanding of the latest technologies pertaining to human genomic research in industry including NGS, genotyping, RNA expression technologies, somatic alteration analysis, bioinformatics, and molecular biology techniques.
- Experience with regulated laboratory environments preferred.
- Superior scientific and technical skills in the genomic sciences.
- Self-motivated and ability to work independently in a high complexity setting.
- Strong organizational ability; ability to successfully work and get things done in teams.
- Ability to engage, communicate and facilitate communication across groups.
- Ability to identify and implement new technologies.
- Ability to design and develop assays for either RNA expression or DNA genotyping/sequencing assays.