Associate Director/Director of Technology Transfer

2 weeks ago

Morrisville, United States SAGA Diagnostics Full time

SAGA Diagnostics is a personalized cancer diagnostics and disease monitoring company focused on molecular genetic analysis of circulating tumor DNA (ctDNA). The company's mission is to improve precision cancer medicine, provide more accurate treatment monitoring, and improve patient survival using minimally-invasive liquid biopsy cancer testing services. SAGA's proprietary tests can help patients, oncologists, and drug developers detect actionable mutations, stratify patient groups, and monitor treatment response, residual disease, and disease recurrence at unprecedented sensitivity and scale.

SAGA Diagnostics recently established a US operation in RTP and is looking for a Director of Technology Transfer to lead a high-functioning team focused on the deployment our assays within the high throughput RTP-based clinical lab and monitoring the performance of the assays in production.

The Director of Technology Transfer will execute development projects varying in size and complexity as part of the testing, validation and implementation of our novel MRD assays in our high-throughput molecular diagnostic laboratory. We are seeking a highly motivated scientist with strong experience in automated assay deployment, project management, data analysis, KPI monitoring and troubleshooting in regulated, high throughput environments. In addition to the criteria below, the ideal candidate must be a skilled team leader with strong negotiation and influencing skills, be able to work independently, handle multiple tasks in parallel, and communicate effectively with all levels of the organization. The ideal candidate has experience in developing and qualifying processes for CLIA/CAP or IVD product(s).

This is an exciting opportunity to help form a team and work closely with an exceptional R&D team based in Lund (Sweden), Cambridge (MA) and a highly experienced Clinical Operations team (RTP). As an early member of the RTP team, you will be responsible for organization of analytical validation studies, data analysis and troubleshooting, support for regulatory submissions, process monitoring and process improvement in the RTP lab. You will be Joining SAGA at an exciting time, we are rapidly scaling our cancer genomics offering with excellent momentum, international attention, and strong customer traction. You will be able to help grow the company and make a real difference for people with cancer worldwide.

Key Responsibilities:

    • Provide management and leadership skills to drive execution on project goals. Continuously analyze and manage risks to enable successful project completion.
    • Manage, mentor and coach scientists and engineers of varying levels of experience.
    • Led the deployment of assays within RTP, including tech transfer, training and coordinating analytical validation studies.
    • Responsible for data analysis of KPIs, and process monitoring of deployed workflows to identify areas for process improvement.
    • Complete holistic reviews of our assays/products and work with the R&D team and Clinical Operations team to identify solutions to troubleshoot and streamline SAGA's assays.
    • Collaborate cross-functionally to create, execute and communicate overall project plans (scope, schedule, budget, resourcing, quality, risk management) and revise them appropriately to meet changing project needs and requirements.
    • Responsible for the execution of studies in support of the integration, verification and validation of automated molecular biology and next-generation sequencing assays under CLIA/CAP/QSR and design control.
    • Serve as the technical expert to help troubleshoot deployment challenges by working closely with the clinical operations team and R&D team. Resolve issues quickly to support continued flow of business.
This role would suit someone who enjoys rolling up their sleeves to deploy assays and wants to work in a fast-paced environment and a willingness to roll up your sleeves - a 'can do' attitude.

Requirements

Required Qualifications:
  • Experience: Requires a Bachelor's degree and typically a minimum of 7 years of process development experience in a related field (preferably in molecular diagnostics) with 4 years leading projects and programs; advanced degree in science or engineering desired. Background in working in a regulated environment, ideally CLIA/CAP. Experience in validating NGS or Molecular Biology assay would be advantageous.
  • Technical mindset: Self-starter with superior problem-solving, analytical and organizational skills and a track record for high performance and superior delivery. Excel at bringing structure to complex, unstructured problems, with a proven ability to research information, solve challenging technical issues, and manage projects under tight timelines.
  • Leadership and Mentorship: Experience with direct management of scientists and engineers of all levels. Ability and willingness to wear multiple hats in the laboratory and throughout the project lifecycle to enable success of the company and specific projects. Demonstrated leadership including ability to identify key issues, motivate and empower others to address them in a way which builds morale, generates ownership and commitment.
  • Laboratory Skills: Showcase strong experimental laboratory and data analysis skills (R, JMP, Python) through a track record of work experience in the field.
  • Clear communicator with a passion for working across teams, including automation, research and development and operations.
Benefits

What we offer:
  • The opportunity to join a team that is developing and optimizing cutting-edge workflows for genomic diagnostics with autonomy and resources to deliver at the highest level.
  • As an early employee of the RTP site you will be involved in every aspect of the business and help set the direction/culture as we grow.
  • The opportunity to build a strong technology transfer team from the ground up.
  • A comprehensive benefits package including medical, dental, vision, flexible spending accounts, parental leave, and opportunities for company equity.
  • All the perks of a start-up - highly competitive salaries, great IT, team dinners/socials, flexible working, flat structure, and a dynamic work environment.


Primary location: Morrisville, NC

Hours: This is a full-time position. Some travel to other SAGA sites is expected for this position.

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