Do you want to be one of the first employees in a new venture, where you will be able to play an active role in driving results, leading to opportunities for rapid career progression?
Does working for a lab that leverages exceptional scientific rigor, a commitment to client-first engagement, and a depth of expertise in Standard of Care, interest you?
Do you want to know if your work will have a real impact on patient care and outcomes?
Are you ready to bring your skills and experience and work under the guidance of some of the top scientific minds in the NGS field?
If your answer to these questions is an emphatic “yes” and you are ready to help lead an established segment leader, with an exceptional reputation in diagnostic testing drives a strategic expansion into genomic sequencing for Oncology, we need to hear from you.
@Orchard LLC has been asked to assist a firm already known for exceptional capabilities in the areas of diagnostic testing as they embark on a new venture and expansion. Our client has created a new Biosciences Division and is building a state-of-the-art lab in New Jersey to provide specialized genomic and molecular pathology (MP) contract services for biopharma and standard-of-care patient testing. The services provided will assist in the research, development, and commercialization of new products for companies in the pharmaceutical and biotechnology space, with an emphasis on Oncology. In support of the highly advanced genomics and MP services, our client is developing a turnkey offering for biopharma clients with central lab work, including sample kitting and logistics management for clinical trials. Our client has put in place the key scientific leaders, and are now embarking on the next phase, which is to start building bench scientists who will deliver on the promise of this exciting opportunity.
If you have been looking for an opportunity to leverage your analytical and bioinformatic skills and experience in NGS, Molecular and Oncology testing, and join a brand-new cutting-edge operation, committed to providing a level of service to biopharma clients that will be second to none, then we need to hear from you. Our client’s facility is located just outside Princeton, NJ, and will provide an exceptional working environment from a firm already recognized as a Top Place to Work.
As an Analytical Scientist, you will.
Apply your training, education, and experience to develop, validate, qualify and implement NGS tests for tumor FFPE tissues, and cell-free DNA (cfDNA), somatic, as well as germline gene alterations. Based on your experience and level, you will function as a subject matter expert for analytical method issues and perform the essential bench-work.
Key responsibilities and tasks will include;
- Lead and participate in tech transfer of analytical methods.
- Contribute to method validation plan and drafting testing protocol and standard operating procedure (SOP).
- Evaluate and implement applicable reference materials and assay QC parameters applicable to NGS, and apply the suitable assay orthogonal testing, e.g. PCR, and ddPCR to verify an NGS assay.
- Coordinate with Bioinformatics group, internally and externally, to process sequence data into reportable genetic calls.
- Contribute to and draft assay validation reports and prepare scientific presentations and deliver them to project teams and management. Following assay validation, perform clinical sample testing.
- Support department and corporate goals in NGS.
- Review and approve protocol/procedure deviation investigations, and work with QA representative to establish corrective action/preventive action (CAPA) plan.
- Independently interpret data from performed experiments and consult with the NGS lead and management as needed. Maintain excellent documentation of experiments and studies.
- Troubleshoot and optimize assay performance in conjunction with the manager and peers.
- Report on project progress and present data effectively at team and management meetings.
- Assist with lab organization and compliance with lab safety protocols.
- Comply with the federal and local lab regulatory requirements including but not limited to CLIA and follow applicable rules and guidelines.
Your background will include.
- Ph.D. in Cell and/or Molecular Biology, Biophysics, Biochemistry, or a related discipline preferred with 3+ years of hands-on experience in NGS at a clinical lab, pharmaceutical company, and/or academic institution. A master’s degree with more than 5 years of directly relevant experience will also be considered.
- Demonstrated experience in NGS method development on Illumina TSO500 (preferred) or any other Illumina platforms, including library construction, sequencing, BI interpretation, and reporting.
- Demonstrated experience in nucleic acid extraction from tissues as well as plasma, manually and via automated extraction is required.
- A deep understanding of molecular biology and biochemical techniques relevant to assay development.
- Strong analytical and troubleshooting skills demonstrated through examples of projects supported.
- Excellent verbal and written communication skills with a particular emphasis on clear documentation of experiments and studies are essential, as is a willingness to collaborate cross-functionally in a fast-paced and dynamic environment.
If you believe you have the experience above, and the desire to participate in creating a new solution-set within the genomic sequencing space, one that marries the best from standards of care and biopharma, then, we are waiting to speak with you.