Staff Scientist, Product Support

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, Product Support role will lead and oversee a variety of technical support activities within Operations. This position will investigate issues through root cause analysis and implement correction actions through use of the Quality Management System supporting Production and Quality Control groups through continuous improvement. Essential Duties Include, but are not limited to, the following: Provide technical and product support leadership in Operations working cross-functionally with the Production, QC, Supply Chain, R&D, and Quality teams. Lead troubleshooting of Out of Specification events (OOS), non-conformances (NCMRs), and corrective action preventive action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis, and reporting. Lead moderate to highly complex projects.  Able to generate plans, identify project and business risk, and communicate progress and status to Operations Leadership.  Lead team execution toward project milestones according to project timelines and apply recognized project management and scheduling tools. Provide technical leadership and support for PCR-based and/or NGS-based reagents and products. Provide support to Operations teams for qualifying new raw materials and alternative supply channels for products. Lead investigations into analytical and functional test methods and associated equipment during the transfer process of methods into operations. Develop analytical test methods and characterize complex manufacturing processes incorporating industry standard techniques. Characterize assay and formulation variability using Measurement System Analysis (MSA) and Design of Experiment (DOE) for complex systems. Clearly and accurately generate experimental protocols, draft work instruction and test method procedures, and summarize development activities through technical summary reports.Program, operate, and troubleshoot complex instrumentation such as microplate readers, real-time and digital polymerase chain reaction (PCR) instruments, next-generation sequencers, and liquid handling automation. Apply basic and advanced statistical techniques: assessing data normality, control charting and data trending, hypothesis testing, assessing variation, linear regression and model fitting, DOE, MSA, Multivariate Analysis, and ANOVA. Analyze data to identify trends, assists/leads troubleshooting and root cause investigation efforts with ability to utilize recognized root cause analysis tools. Leads investigations into complex analytical and functional assays, associated equipment, materials, and/or processes, leads CAPA plans. Write new and edit existing Quality System documents (e.g. work instructions, standard operating procedures).  Identify Continuous improvement opportunities for the Quality System.  Responsible for generating/driving corrective actions/action plans for more complex changes. Collaborate with other departments (Quality Engineering, R&D, Regulatory Affairs, Supply Chain, Production, Validation, Quality Control) to achieve business results.  Able to meet objectives without negatively impacting other functions. Lead low to moderately complex projects at a program level.  Generate project plans, identify risk, and communicate status to Operations Leadership.  Lead team execution toward project milestones according to project timelines and apply recognized project management and scheduling tools. Function independently with limited guidance from supervisor as well as part of a team.  Capable of leading teams to achieve business results. Proactive and forward thinking to plan and shift directions based on priorities/need. Excellent verbal and written communication skills. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company’s Quality Management System policies and procedures. Maintain regular and reliable attendance. Ability to act with an inclusion mindset and model these behaviors for the organization. Ability to work nights and/or weekends, as needed. Ability to travel 5% of working time away from work location, may include overnight/weekend travel. Minimum Qualifications Bachelor’s degree in life sciences or field related to the essential duties of the job. 10+ years of experience in the life sciences industry. Master’s or Doctoral degrees may be considered in lieu of 2 years of experience. 6+ years working within an FDA 21 CFR 820, ISO 13485, ISO12207, and/or cGMP structured environment. Proficient in MS Office Suite (Word, Excel, Outlook, PowerPoint). Demonstrated ability to perform the essential duties of the position with or without accommodation. Authorization to work in the United States without sponsorship. Preferred Qualifications Proficiency with statistical analysis software and/or programing (e.g. JMP, R). Advanced Degree in Biology, Chemistry, or similar discipline (MS, PhD). Experience developing automated liquid handling workflows on Hamilton robotic platforms. Experience with in-vitro diagnostic product development, design transfer, manufacturing, or product support. Strong knowledge of continuous improvement methodologies/principles. Six Sigma Green Belt (or higher) Certification. Familiarity with Project Management Principles and Practices. Experience using Enterprise Resource Planning (ERP) software (SAP preferred). Experience using Electronic Quality Management System (EQMS) software (Agile preferred). Familiarity with CAP/CLIA regulatory requirements as they pertain to in vitro diagnostics. #LI-AT1 Salary Range: $129,000 - $168,000   The annual base salary shown is for this position located in US - CA - San Diego on a full-time basis. In addition, this position is bonus eligible. Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits. Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here. Not ready to apply? Join our Talent Community to stay updated on the latest news and opportunities at Exact Sciences. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law. 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