Job Description

Technical Director Molecular Pathology

Princeton area, New Jersey

Are you ready to be both a hands-on expert and a leader of a team of experienced Technical Pathology Scientists and Bench Technicians tasked with developing new assays and evaluating off-the-shelf assays to be utilized by biopharma clients and to impact patient outcomes?
Do you want to work for a firm that already has a market-leading position in testing and is now leveraging its expertise into the area of Next Generation Sequencing and Oncology in particular?
Can you be a subject matter expert, and an inspirational leader, tasked with being one of the first leaders building a new molecular pathology lab infrastructure and team?
Do you believe that building an innovative, best-in-class team and combining them with exceptional technology and a research mindset can make a lasting impact for good?
Do you want to be a leader and a part of the integration between standards of care and Biopharma, driving real impacts in patient care and outcomes?
If your answer to these questions is an emphatic \xe2\x80\x9cyes\xe2\x80\x9d and you are ready to help lead an established segment leader, with an exceptional reputation in diagnostic testing to drive a strategic expansion into genomic sequencing and molecular pathology 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 has built a state-of-the-art lab in New Jersey to provide specialized genomic and anatomic pathology contract services for biopharma as well as for 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. If you have ever wanted to put your technical and leadership skills to the test, in an environment where your ideas and concepts will be given free rein, then this is just the role you have been waiting for.

As the Technical Director, Molecular Pathology you will;
Lead the tissue staining and other molecular pathology techniques related to immunohistochemistry (IHC) immunocytochemistry (ICC) and in-situ hybridization (ISH/FISH/CISH) functions at the client. The objective is to develop and validate novel assays and to validate or verify off-the-shelf kits to be offered to clients conducting both pharmaceutical clinical trials and standard patient care.

Some of your responsibilities include.

• Lead, oversee, train, manage, and demonstrate to bench technologists and junior scientists to develop, optimize, and validate assays.
• Roll sleeves and work on the bench and coach/help a team of technical pathology scientists and technicians establish an assay from commercially available raw materials or troubleshoot a technical issue - about 25% of your time on average.
• Suggest, qualify, and use materials as positive and negative quality control for each assay.
• Search the market or literature to elect technology and reagents for single antibody and multiplex assays based on biomarker staining pattern and purpose of an assay. Provide expert advice on biomarker selection, characterization, and development for exploratory research, cancer screening, or diagnostic purposes.
• Assess and monitor the strategic position and marketplace presence of key competitors in IHC, ICC, and ISH, and provide scientific input to our client\'s market strategy and competitive positioning.
• Participate in sponsor, CRO, and investigator meetings as requested by the business development team or project management.
• Serve as the subject-matter expert and provide consultation and address client questions in real-time.
• Help biopharma clients in developing and implementing IHC/ISH-based biomarkers in translational or late-phase clinical trials.
• Manage the design, conduct, interpretation, and reporting of biomarker data/activities in line with drug development, regulatory, and commercial strategies.
• Design assay development and validation plans that fit a client\'s purpose of an assay, draft SOPs, assay validation reports, and clinical study reports.
• Interact with the CSO and other functions to ensure appropriate resources are established to direct assay development or assay transfer and its implementation.
• Provide the instructions for sample acquisition, processing, storage, shipping, and handling needed for a lab manual.

Your background will include.

• Ph.D. in one of the biological sciences with 8+ years or MS with 10+ years of experience in IHC, ISH, and ICC at a CRO lab, pharmaceutical company, and/or medical institution.
• Demonstrated capabilities for establishing, developing, optimizing, and validating novel singlet and multiplex IHC, single-probe, and dual-probe ISH assays in FFPE tissues.
• Experience in ICC and CTC phenotyping is a plus.
• Provide examples of experience in taking an assay from a hypothesis to utilization in clinical sample analysis with needed quality measurements.
• Knowledge of pharma clinical trial assay, regulatory requirements governing clinical laboratory, companion diagnostics, and/or in vitro diagnostics is preferred.
• Experience in qPCR and dPCR is preferred.
• Proven ability to manage clinical translational programs and teams with minimal supervision.
• Self-organized and operates effectively without significant day-to-day oversight, while following the CSO\'s high-level instructions and staying connected to key stakeholders.
• Strong interpersonal, organization, time-management, people management, and communication skills.
• Collaborative and teamwork skills.

If you believe you have the experience above, and the desire to lead in creating a new solution within the genomic sequencing space, one that marries the best from standards of care and biopharma then, we are waiting to speak with you.

Established in 2010, @Orchard LLC, also known as, Talent Orchard has an exceptional reputation, providing staffing solutions to time-sensitive, talent scarcity issues to deliver better talent management ROI. Our specialty lies in the critical area of program talent acquisition and resource management, not in one narrow skillset, but across many areas of technical and functional delivery. To learn more about our other exciting opportunities, visit our Jobs Page at .

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