Staff Scientist, QC Software and Assay Transfer

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At Exact Sciences, we're helpingchange 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, QC Software and 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 bioinformatics and software assay transfer process into Operations by working cross-functionally with the quality control, research and development, systems development, and quality engineering teams.
• Lead test method QC software 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.
• Lead development and characterization of analytical and functional test method QC software with comprehensive understanding of their use in Operations and QC.
• 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.
• Lead the use of 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.
• Lead troubleshooting, functional assays, analytical methods, and associated analysis software.
• Lead the development and validation of QC software pipelines and associated test methods.
• Lead the design and execution of complex studies and designed experiments; provide thoughtful leadership and mentorship.
• Expert in clearly and accurately generating experimental protocols, drafting work instruction procedures, test methods, and summarizing development activities through technical summary reports.
• Support Process Validation and leads 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.
• Lead others in creation of 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 maintainmorale 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 ability to work effectively in team situations, as well as independently.
• Exercise excellent oral and written communication, interpersonal, and presentation skills with strong attention to detail.
• Exercise ability to prioritize tasks and/or renegotiate timelines, takes calculated risks to exceed expectations, and adhere to project schedules and timelines.
• Exercise ability to proactively plan with the ability to navigate through ambiguity and thrive in a fast-paced, frequently changing, and evolving environment.
• 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 on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• Ability to lift up to 40 pounds for approximately 5% of a typical working day.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to use various types of laboratory equipment; including microscopes, microtomes, blades, strainers, and pipettes for extended periods of time.
• May perform repetitious actions using lab tools.
• Ability to use near vision to view samples at close range.
• May be exposed to hazardous materials, tissue specimens, and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
• Ability and means to travel between local Exact Sciences location(s).
• 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.
• 8+ years of experience in the life sciences industry.
• Master's or doctoral degree may be considered in lieu of 2 years of experience.
• Proficient in a variety of basic, intermediate, and advanced laboratory skills and techniques.
• Strong knowledge base in Chemistry, Biochemistry, Molecular Biology, or a related field.
• Expert understanding of IVD product Manufacturing processes and relevant assays (e.g. biochemical, RT-PCR, NGS).
• Proficient in MS Office Suite (Word, Excel, Outlook, Power Point).
• 4 years working within an FDA 21 CFR 820, ISO 13485, ISO12207, and/or cGMP structured environment.
• 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 (ex. 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.
• Familiarity with Project Management Principles and Practices.
• Experience using Enterprise Resource Planning software (SAP).
• Familiarity with CAP/CLIA regulatory requirements as they pertain to in vitro diagnostics.
• Experience with Linux-based HPC or cloud computing environments and associated tools.
• Familiarity with programming or scripting languages.

Salary Range:

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.

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