Staff Scientist, Assay Transfer and Method Development

Help us change lives

At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

Position Overview

The Staff Scientist, Assay Transfer role will lead and coordinate a variety of design and test method transfer activities within Operations. This position is primarily responsible for leading the transfer and implementation of analytical and functional tests used to characterize and release products in operations.  Additional responsibilities include collaboration with other departments to define test method requirements and development of new methods as needed.   

Essential Duties

Include, but are not limited to, the following:

• Lead and oversee the assay transfer process into Operations by working cross-functionally with the production, quality control, supply chain, research and development, systems development, and quality engineering teams.
• Lead test method development and transfer via test method transfer forms/plans, characterization studies, method development reports, and quality specification documents through collaboration, experiment design, study execution, data analysis, and reporting.
• Able to lead development and characterize analytical and functional test methods with comprehensive understanding of their use in Operations and QC.
• Able to lead characterization of test method variability, design and coordinate execution of Measurement System Analysis studies and determine specifications.
• Lead training and knowledge transfer of test method development and execution. 
• Program and operate complex instrumentation; including, but not limited to, micro plate readers, real-time polymerase chain reaction (PCR) instruments, analytical instruments such as high-performance liquid chromatography (HPLC), auto titrators, densitometers, and spectrophotometers, and liquid handling automation.
• Able to use data analytics and statistical tools to monitor and identify trends, oversees troubleshooting and root cause investigation efforts at a Product or Test Method level, and manages priority based on business need.
• Leads investigations into analytical and functional test methods and associated equipment during the transfer process of methods into Operations.
• Troubleshoot automated liquid handling instrumentation, detection equipment, functional assays, and analytical methods.
• Support the development and validation of automated liquid handling instrumentation and methods.
• Oversee the design and execution of complex studies and designed experiments; provide thoughtful leadership and mentorship.
• Able to clearly and accurately generate experimental protocols, draft work instruction procedures, test methods, and summarize development activities through technical summary reports.
• Support Process Validation and lead Test Method Validation readiness and execution. Provides support and review in generating Validation documentation.
• Expertise in statistical techniques:  assessing data normality, control charting & data trending, hypothesis testing, assessing variation, linear regression and model fitting, DOE, MSA, Multivariate Analysis, and ANOVA.
• Able to generate plans and timelines, identify project and business risk, and communicate progress and status to Operations Leadership. 
• Leads team execution toward project milestones according to project timelines without negatively impacting other functions.
• Applies recognized PM and scheduling tools.
• Write new and/or edit existing Quality System documents.  Responsible for generating and/or driving corrective actions or action plans.  Collaborates with Quality to mitigate product or process level risk.
• Expertise in continuous improvement methodologies/principles.
• Exercise ability to maintain morale and support employee engagement initiative when leading cross-functional teams or serving as a mentor.
• Demonstrates self-motivation and ability to function independently, influence others, deliver on team vision, and hold partners accountable to timelines.
• Exercise ability to effectively communicate with multi-level personnel, as well as outside vendors and their representatives.
• Exercise strong strategic agility, business acumen, and vision.
• Ability to influence and inspire individuals outside Operations, hold others accountable, drive decisions to completion, and build policies when gaps are identified.
• Exercise strong analytical, problem solving, and decision-making skills.
• Display ab