Director of Laboratory Operations @ Correlagen Diagnostics
PhD, Molecular Genetics @
The University of Glasgow
I am an experienced Laboratory Director with 15 years of experience in clinical molecular diagnostics, most recently in Next Generation Sequencing in the Oncology space. I have extensive experience in assay development, technical transfer to a production environment, and laboratory operations management in CLIA, CAP and NY State certified clinical laboratories running highly complex assays. I am
I am an experienced Laboratory Director with 15 years of experience in clinical molecular diagnostics, most recently in Next Generation Sequencing in the Oncology space. I have extensive experience in assay development, technical transfer to a production environment, and laboratory operations management in CLIA, CAP and NY State certified clinical laboratories running highly complex assays. I am experienced in identification, evaluation and execution of new business opportunities. I am recognized for professionalism, an innovative approach, know-how, and the ability to build, motivate and manage cohesive teams at all levels of the organization. I have a proven track record in leadership, new assay design, clinical diagnostic performance, technical writing, new product identification, and regulatory compliance.
Director, Sequencing Operations @ From June 2015 to Present (7 months) Director, Central Laboratory @ Responsible for the overall operation and administration of the CLIA laboratory, including employing/supervising personnel who are competent to perform test procedures; generating test results and patient reports promptly, accurately and proficiently; and assuring compliance with the applicable state and federal regulations.
•Manage direct reports and day-to-day laboratory operations for a cutting edge next generation sequencing laboratory. Oversight of >30 laboratory technicians, technologists, supervisors and managers. Direct supervision of 14 employees (1 manager, 2 supervisors, 11 technicians).
•Ensure that samples are processed within our published turnaround times.
•Provide leadership, guidance, and troubleshooting expertise in all functional areas of the assay.
•Collaborate with QA/regulatory/compliance teams to ensure that appropriate quality control programs are established and performed in the lab.
•Work directly with LIMS team to improve user experience, add new functionality, generate reports for data analysis including troubleshooting and identification of areas for improvement.
•Oversight of annual review of policies and procedures pertaining to the clinical laboratory.
•Coordinate and execute laboratory process improvements and upgrades from concept through experiment to implementation.
•Principle laboratory representative in the Pharma Operations, Commercial Operations, QA Monthly Processing Metrics, QA Department Management and CAPA Review, and Process Improvements teams. From October 2010 to June 2015 (4 years 9 months) Director of Laboratory Operations @ Accomplishments include:
• Assisted with the design and validation of Correlagen’s Next Generation Sequencing product, the Cardio Gene Scan (CGS), the first commercially available assay of its size and type.
• Designed and established diagnostics core competency laboratory and high throughput liquid handling automation platform for R&D and Operations from the “ground up”, and subsequently managed process to obtain MA State, CLIA and CAP certification. The laboratory was licensed by all state agencies that require licensure.
• Hired and managed a team of direct reports including technologists, PhD scientists, regulatory specialists and automation specialists. Oversaw training, skill enhancement, and internal career growth.
• Developed and managed an annual operating budget based on expected sample volume.
• Managed the design and development of over 40 DNA PCR and Sequencing based CLIA standard assays available through Athena Diagnostics.
• Managed the design and development of over 30 DNA PCR and Sequencing based CLIA standard assays available through Correlagen Diagnostics.
• Introduced new automation amenable methodologies for PCR and Sequencing that facilitated clinical performance of over 800 amplicons at one single uniform condition.
• Designed, introduced and supervised all lab based operating protocols and procedures ensuring all protocols stayed current with active procedures. Lead role in continued process development improvements.
• Designed and implemented Laboratory QA/QC policies in collaboration with external compliance specialists.
• Manage the processing of an average of 12,000 amplicons of clinical product per month with the release of over 300 CLIA certified clinical reports per month.
• Managed the outsourcing of sequence analysis and QA package assembly with VeriskHealth located in Kathmandu, Nepal (5 employees). From April 2004 to September 2010 (6 years 6 months) Scientist II @ Accomplishments include:
• Team leader on over 10 key projects requiring interactions with R&D, IT (LIMS), operations, marketing, finance and sales departments; Consistently met assay launch deadlines.
• Implementation of cost reduction strategies, Savings of >500K in 2003 with continued efforts to reduce laboratory overhead costs.
e.g. Initiated laboratory cost reduction project with the upgrade of 6 assays to single strand sequencing. Responsible for implementation of M13 tagged PCR primers that led to universal sequencing conditions. Responsible for significant cost reduction by the reduction by half of AmpliTaq Gold (PCR) and BigDye (sequencing) volumes in assay reactions without impact on quality of assays.
• Identification of potential new products including key role in evaluation of collaborative opportunity with Correlagen Diagnostics; Intellectual Property searches; Interactions with legal departments; Negotiation of licensing royalties, terms and conditions.
• Interaction with the technology transfer departments of Academic Institutions regarding technology and material transfers.
• Preparation of non-disclosure agreements, material transfer agreements, term sheets and licensing documentation.
• Preparation of assay development to meet requirements of a CLIA certified clinical testing laboratory, College of American Pathologists (CAP), Joint Commission of Healthcare Organizations, and all applicable US states.
• Preparation of standard operating procedures (SOPs), assay validation, patient informed consents, clinical validation, technical validation.
• Responsible for conversion of Sequencing department software to ABI SeqScape software (23 assay validations).
• Launched first Athena Diagnostics offering of family member testing (single amplicon testing) for TSC in close collaboration with the Tuberous Sclerosis Alliance. From August 2000 to April 2004 (3 years 9 months)
MBA, Business Administration @ Clark University From 2001 to 2005 PhD, Molecular Genetics @ The University of Glasgow From 1989 to 1997 John Curran is skilled in: Lifesciences, Molecular Biology, Biotechnology, Quality Assurance, DNA, Genomics, Genetics, Life Sciences, Laboratory, Cancer, Biochemistry, R&D, Oncology, Pharmaceutical Industry, GLP
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