Logan AC, Zhang B, Narasimhan B, Carlton V, Zheng J, Moorhead M, Krampf MR, Jones CD, Waqar AN, Faham M, Zehnder JL, Miklos DB. Source Department of Medicine, Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, CA, USA.

Experience & Qualifications:

• Required – Applicants must hold a current California Clinical Laboratory Scientist (CLS) or Clinical Genetic and Molecular Biology Scientist (CGMBS) license and a Bachelors’ degree in biological sciences or medical technology.
• >2 years’ experience in a California CLIA certified laboratory, with a minimum of 1 year experience in Molecular testing preferred
• Experience with nucleic acid extraction, PCR, and sequencing (next generation sequencing) is preferred
• Excellent laboratory skills, strong verbal and written communications skills are necessary
• Have the ability to thrive in a challenging, highly diverse team environment
• Working knowledge of laboratory functions (ex. LIS, LIMS, Quality, etc.)

Responsibilities:

• Accurately perform molecular testing, using a variety of molecular biological techniques including next generation sequencing
• Conduct daily quantitative and qualitative assessment of molecular data generated during the course of testing
• Carry out QC/QA activities as part of the company’s Quality program and commitment to patient safety
• Participate in a variety of other essential laboratory activities, including reagent qualification, inventory management, procedure writing, inspection preparation, test validation, and equipment maintenance
• Proficient performing nucleic acid extraction and running test on next generation sequencing platform
• Organize workflow to test patient samples and report results efficiently and accurately following Standard Operating Procedures
• Participate in the development and validation of new assays and technology transfer from development to CLIA
• Support accessioning operations of clinical samples
• May train and supervise Lab Assistants
• Capable of identifying problems that may affect test performance or reporting of test results
• Work schedule may be modified to meet operation requirements.  Applicants must be flexible in work time and shifts.

Apply via Email

Job Description:
Biotech start-up, Sequenta, Inc. is looking for a highly energetic and motivated individual to play a vital role in the day-to-day operations of this growing company. This multi-faceted role will support all aspects of the organization. Primary duties center on procuring materials, services and lab supplies as needed by the various labs, including our commercial CLIA lab. 

This position will report to the VP of Finance and Administration.

Responsibilities:

• Procuring materials, services and lab supplies 
• Maintain appropriate stocking levels for consumables and other supplies
• Develop and manage supplier relationships
• Research and evaluate vendor reliability: monitor costs and quality to assure best quality at best value
• Maintain purchase order log for entire organization
• Manage lab equipment’s maintenance and calibration schedules and contracts
• Responsible for capital equipment tracking (asset tag log)
• Receiving of purchased materials; verify against purchase order
• Receiving of clinical samples
• Responsible for routine interactions with hazardous materials waste disposal company
• Back-up to office manager for general facilities issues

Skills & Experience:
Candidate must be familiar and comfortable with working in a small, start-up environment, and adaptable to working with all levels of the organization. The successful candidate will be a proven self-starter, energetic, timely and organized, with excellent written and oral communication skills. College degree preferred- BS or BA in business or related discipline. Three years of solid experience in purchasing and/or lab services in the biotech or medical device industry is desirable, with experience  in negotiating contracts. Candidates with knowledge of forecasting, scheduling, and planning will be preferred.

“The launch of ClonoSIGHT marks an important step toward improved treatment paradigms in blood cancers which are driven by sensitive and specific measurements of residual disease,” said Tom Willis, Ph.D., Sequenta’s chief executive officer. “This product builds on more than two decades of clinical research into the value of MRD and brings the incredible power of next-generation sequencing to bear on the important problem of rare cancer cell detection.”

The ClonoSIGHT test uses Sequenta’s proprietary LymphoSIGHT™ platform, which works by sequencing unique DNA signatures that are present in immune cells to allow tracking of malignant sub-populations even when they are present at levels as low as one cell per million white blood cells. The sequencing-based readout provides quantitative results that can be directly interpreted by oncologists.

“The LymphoSIGHT technology has been validated in the past year in more than 10 clinical trials, two of which have already appeared in peer-reviewed journals, with others under review,” said Malek Faham, M.D., Ph.D., chief scientific officer at Sequenta. “These studies have demonstrated not only the technical improvements in sensitivity and specificity of the ClonoSIGHT test, but also the relevance of its performance for patient prognosis in acute lymphoblastic leukemia (ALL), mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).”

These early studies have shown that the LymphoSIGHT method was able to detect residual disease in as many as 10 percent of children with ALL who were negative by flow cytometry. It also detected residual disease in significant numbers of MCL patients who were negative by PET scans and subsequently suffered fatal relapses. Larger studies, including prospective studies conducted by oncology cooperative groups, are currently underway to extend the validation of the test.

About Sequenta, Inc.

Sequenta is a venture backed startup dedicated to improving patient care in diseases mediated by immune cells through measurements of lymphocyte diversity. It is commercializing its LymphoSIGHT™ platform for clinical use in minimal residual disease while continuing to validate the use of its technology in a diverse set of diseases. For more information, go to www.sequenta.com.

Job Description:
Implement Sequenta’s sales strategy to meet a sales forecast in the first year of launch while planning for market expansion in year 2 and beyond. Initial customer list will be in place so initial tasks are directed at developing a sales forecast, getting customers needed information for ordering, ensure all relevant patients are being considered for testing, handling messaging of the company’s reimbursement plans and communicating marketing messages relating to upcoming launch features. As test use expands, collaborate with management to develop sales force planning and recruit new sales staff as needed. Be the voice of the customer within the company to ensure that the needs of the customers are being heard so that the company can ensure that these needs are met operationally and through product planning.

Experience:
>10 years’ experience in clinical product sales, diagnostic product sales experience strongly preferred sales within the oncology practice desirable. Familiarity with DNA related technologies and a facility with technical concepts (sensitivity vs. specificity, PPV vs. NPV) in clinical testing knowledge of lymphoid cancer and its treatment a plus.

Job Requirements:
The candidate will report to the CEO. Expected to travel to customers on a routine basis (expectation of travel: 30% of time). Candidate will be expected to work with CEO to develop and deliver to a forecast. Compensation will be partially tied to sales goals. Candidate will be expected to be in SSF headquarters at least every other week but does not necessarily need to relocate if not local.

Gawad C, Pepin F, Carlton V, Klinger M, Logan AC, Miklos DB, Faham M, Dahl G, Lacayo N. Blood. 2012 120(22):4407-17.

Faham M, Zheng J, Moorhead M, Carlton VE, Stow P, Coustan-Smith E, Pui CH, Campana D. Blood. 2012 120(26):5173-80.

Combined with two studies previously published in BLOOD, a total of six clinical studies have firmly established the value of the LymphoSIGHT™ method for MRD assessment in adult and pediatric ALL patients and demonstrated more comprehensive MRD coverage compared to flow cytometric and allele-specific oligonucleotide polymerase chain reaction (ASO-PCR) methods.

LymphoSIGHT™ is the core technology that serves as the basis for Sequenta’s commercial product, ClonoSIGHT™.

“The studies presented at ASH, representing more than 300 ALL patient samples, form the basis of a strong clinical validation of our approach to MRD testing,” said Sequenta CEO Tom Willis. “These and other ongoing studies make our ClonoSIGHT™ assay the only clinically validated sequencing approach to immune cell monitoring.”

The LymphoSIGHT™ method utilizes a proprietary assay for the amplification and sequencing of immunoglobulin and T cell receptors, demonstrating:

• n Increased sensitivity (ability to detect cancer at levels of one cell per million white blood cells)
• n Increased coverage of all patients (more than 95 percent calibration rate at diagnosis)
• n Universal and scalable assay yielding robust data

In addition, the platform has revealed underappreciated disease heterogeneity. The platform’s ability to measure the full spectrum of genetically related cancer cells promises to be important in the future.

“The value of MRD in making treatment decisions in ALL is now well established,” said David Miklos, M.D., Ph.D., Assistant Professor of Medicine at Stanford University. “Sequenta’s approach represents the future of MRD testing, allowing clinicians to monitor all disease clones in virtually all patients even when they are present at very low levels.”

ClonoSIGHT™, a Sequenta product that uses the LymphoSIGHT™ method, has now been implemented in Sequenta’s CLIA accredited lab. This test offers deep clonality assessment of blood and marrow samples across multiple immune receptors in a clinical setting and has a seven day turnaround time from blood collection to results.

About Sequenta, Inc.

Thomas D. Willis, Tom Asbury, Victoria Carlton, Lei Fang, PhD*, Mark Klinger, Martin Moorhead, Kaliprasad Pothuraju, Li Weng, Jianbiao Zheng, Malek Faham. (ASH Annual Meeting Abstracts), Dec. 2012; 1434.

Charles Gawad, Michael J. Borowitz, Gary V. Dahl, Meenakshi Devidas, Malek Faham, Martin Moorhead, Brent L. Wood, Jianbiao Zheng, Mignon L. Loh, Norman J. Lacayo. (ASH Annual Meeting Abstracts), Dec. 2012; 1440.