Associate Scientist II, Assay Transfer

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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 Associate Scientist II, Assay Transfer role will assist a variety of design and test method transfer activities within Operations. This position is primarily responsible for assisting 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:

• Provide test method transfer support to operations by working cross-functionally with the production, quality control, supply chain, research and development (R&D), systems development, and quality teams.
• Support test method 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. 
• Assist in training and knowledge transfer of test method development and execution. 
• Able to assist development and characterization of simple functional and analytical test methods with general knowledge of their use in operations and QC.
• Able to assist characterization of basic test method variability, design and coordinate execution of basic Measurement System Analysis studies and determine specifications with support from SMEs for simple measurement systems.
• Support development and validation of automated liquid handling instrumentation and methods.
• Analyze data to identify trends, assists/leads troubleshooting and root cause investigation efforts with understanding of recognized tools. 
• Assists investigations into analytical and functional test methods and associated equipment during the transfer process of methods into operations.
• Able to clearly and accurately generate experimental protocols, draft work instruction procedures, test methods, and summarize development activities through technical summary reports.
• Support Process and Test Method Validation readiness and execution.  Provides support and review in generating Validation documentation.
• Understands and can apply the following basic statistical techniques:  assessing data normality, control charting & data trending, hypothesis testing, assessing variation, basic linear regression and model fitting. 
• Actively participates in project execution.
• Collaborates regularly with other on site departments (QE, R&D, RA, Supply Chain, Production, Validation, QC) to achieve business results.  Able to meet objectives without negatively impacting other functions.
• 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.
• Consistently hits deliverables as outlined by manager.  Pro-actively seeks additional tasks/projects and works with manager to renegotiate timelines based to balance workload.  
• A self-motivated individual that can function both independently with minimal supervision by advisor as well as part of a team is required. 
• Adaptable to rapid changes in priorities, strong sense of urgency, and able to identify ways to work together to achieve results needed for all requests.
• Interpersonal savvy, effective communicator, results oriented, accountable, resourceful, resilient, team player, collaborative, problem solver, detail oriented.
• 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.
• 2+ years of experience in the life sciences industry.
• Authorization to work in the US without sponsorship.
• Demonstrated ability to perform Essential Duties of the position with or without accommodation.
• Proficient in MS Office Suite (Word, Excel, Outlook, Power Point)
• Proficient in a variety of basic laboratory skills and techniques. 
• Basic knowledge in Chemistry, Biochemistry, Molecular Biology, or a related field. 
• Good understanding of IVD product Manufacturing processes and relevant assays (e.g. biochemical, RT-PCR, NGS).
   

Preferred Qualifications

• Proficiency with statistical analysis software and/or programming (ex. JMP, R).
• Experience working within an FDA 21 CFR 820, ISO 13485, ISO12207, and/or cGMP structured environment.
• Experience with in vitro diagnostic product development, design transfer, manufacturing, or product support.

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 E-Mail schreiben.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Any applicant or employee may request to view applicable portions of the company’s affirmative action program.

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