PHYSICAL REQUIREMENTS

• This position requires the individual to wear and work in personal protective equipment.
• This position requires the ability to lift a minimum of 25lbs.
• Substantial movements (motions) of the wrists, hands, and/or fingers are required.
• Required to have close visual acuity to perform an activity such as preparing and analyzing data and figures, writing and reviewing documents, and pipetting small volumes of clear liquids.

ABOUT THE ROLE

The Regulated Assay Development team plays a central role at Foresight, engaging at the interface of science, engineering, and operations, to deliver game-changing MRD detection technologies. Reporting to the Senior Director, Regulated Assay Development, this position requires a flexible and collaborative self-starter with experience leading teams and designing, executing, analyzing, & interpreting complex, multi-factorial experiments. You will be leading a team developing and transferring reagent test methods, implementing process improvements, and supporting products in our CLIA lab to ensure they meet quality and regulatory requirements. This will involve overseeing conduct of laboratory studies to develop, improve, and troubleshoot, as well as cross-training operators to support technology transfer into a production setting. This role will provide the opportunity to work cross-functionally with many different departments, including operations, supply chain, quality, automation engineering, regulatory, and bioinformatics teams, among others. Ideal candidates will be able to come up to speed quickly to create a clear, risk-based test method development roadmap. They will also be capable of building a collaborative team as well as strong working relationships with other cross-functional teams.

WHAT YOU WILL DO

• Lead the development and implementation of strategies for reagent manufacturing and development, aligning with the overall goals of the organization.
• Lead scientists and/or team managers in life cycle management activities for products inclusive of collaborating on risk assessments, regulatory strategy, and design change verification/validation activities.
• Lead the development of manufacturing processes, stability and processing equipment for buffers, enzymes, mixtures, and/or raw materials with unique physical or chemical attributes incorporating industry standard techniques at both small and large scale.
• Work with external vendors, clinical, bioinformatics, and assay development teams to develop specifications for testing and manufacturing reagents and execute routine testing methods for quality testing and release of highly complex reagents.
• Oversee execution of process development, training, and pilot scale manufacturing for moderate and complex processes/products.
• Leverage your technical knowledge and use collaborative skills to work with the internal multi-disciplinary teams, overseeing the development and execution of experimental and analytical strategies to troubleshoot and improve processes.
• Work under design controls and support manufacturing and testing of In Vitro Diagnostic (IVD) medical devices in accordance with ISO13485 and FDA guidelines.
• Identify design defects and process failure modes, conduct risk assessments and manage risk through proper mitigation measures.
• Support and comply with the company’s quality management system policies and procedures.
• Provide clear and concise written and oral communications to colleagues and supervisors.