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About the Company: Haystack Oncology is a precision medicine company based on over two decades of technology and clinical development in the field of liquid biopsy. The mission of Haystack Oncology is to develop and deliver to the clinic a best-in-class personalized cancer diagnostic to identify the maximal number of patients with residual, recurrent, and resistant disease that stand to benefit from proactive clinical interventions. Haystack Oncology's best-in-class MRD test delivers more sensitive earlier detection of lurking disease leading to better chances for cure and aims to benefit all patients with solid tumors. Role: As an onsite member of the Technical Operations team, you will be responsible for defining, developing, and supporting critical production equipment and processes. You will lead the design, development, optimization, and implementation of automated liquid handling processes, systems, and streamlined workflows, with a goal of increasing sample throughput and equipment uptime. Responsibilities: - Serve as a subject matter expert in the design and care of production equipment.
- Collaborate in production automation, working with cross-functional and multinational teams.
- Ensure compliance through document management, nonconformity management, and equipment change management.
- Oversee installation, qualification, and performance validation of equipment according to GMP. (IQ/OQ/PQ)
- Contribute to data production performance by supporting and maintaining equipment, process controls, and automation systems.
- Program and optimize methods, scripts, and protocols for automated platforms.
- Originate or assist in the generation of protocols, reports, and presentations.
- Troubleshoot automation instrumentation and procedures as necessary.
- Integrate sample processing and instrument control with Laboratory Information Management Systems (LIMS) in accordance with Federal Title 21 Part 11.
- Supervise and coordinate activities of 2 to 3 technicians.
Preferred Education and Experience:
- BS/BA degree or equivalent in Engineering or Science required. MS preferred.
- 8 years of relevant experience required working in the medical device industry, in vitro diagnostics, or regulated molecular diagnostics laboratory (CLIA, IVD).
- Equivalent combination of education and work experience considered.
- Hands-on experience with operating and programming liquid handling robotics and robot platforms (Hamilton, Tecan, Beckman Coulter, Perkin Elmer, Bravo, Agilent, etc.).
- Highly skilled in streamlining workflows and developing automated laboratory processes and instrumentation systems, including collecting and documenting requirements, developing concepts, design, testing/validation, implementing, and training.
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