Position Overview
The Senior Associate Scientist I, Product Support will lead and assist in a variety of technical support activities within Operations. This position will investigate issues through root cause analysis and design and implement corrective actions through use of the Quality Management System (QMS) supporting Production, Quality Control, and Supply Chain groups in continuous improvement.
Essential Duties
include but are not limited to the following:
- Provide technical and product support to Operations by working cross-functionally with the Production, QC, Supply Chain, R&D, Clinical Laboratory, and Quality teams.
- Provide technical leadership and support for NGS based reagents and products.
- Lead and support troubleshooting of Out of Specification (OOS), Nonconformance Reports (NCMRs), and Corrective Action and Preventive Action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis, and reporting.
- Provide technical support to the Supply Chain team for sourced materials and perform technical evaluations of alternatively sourced materials.
- Analyze, track, and trend historical Production and Quality Control data.
- Assist in the training and transfer of processes and/or procedures as part of corrective action implementation.
- Generate clearly and accurately experimental protocols, draft work instruction procedures, characterize Test Methods, and summarize activities through technical summary or investigative reports.
- Program and operate complex instrumentation, such as micro plate readers, real-time PCR instruments, liquid handling automation, and next-generation sequencers.
- Conduct bench level experiments within several product or technology areas to identify problems and discrepancies.
- Apply knowledge of working within an FDA regulated 21 CFR 820 environment, ISO 13485, and/or cGMP structured environment.
- Support and comply with the company's Quality Management System policies and procedures.
- Ability to effectively communicate with multi-level personnel as well as outside vendors and their representatives.
- Ability to effectively work on several varied projects at one time, with frequently changing priorities.
- Effective analytical, problem solving, and decision-making skills; ability to work effectively in team situations as well as independently.
- Excellent oral and written communication, interpersonal, and presentation skills; ability to collaborate across functions and within a workgroup to meet business objectives.
- Strong attention-to-detail.
- Ability to prioritize tasks and adhere to project schedules and timelines.
- Ability to thrive in a fast-paced, frequently changing, and evolving environment.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Regular and reliable attendance.
- Ability to work designated schedule, generally standard business hours, Monday-Friday.
- Ability to occasionally work nights and/or weekends.
- Ability to lift up to 50 pounds for approximately 5% of a typical working day.
- Ability to utilize lab equipment for approximately 75% of a typical working day.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 60% 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 work on a computer and phone simultaneously.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability to work with blood, tissue, stool, or other human specimen samples.
- Ability and means to frequently travel between Madison locations.
- Ability to travel 5% of working time away from work location, may include overnight/weekend travel.
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Minimum Qualifications
- Master's degree in life sciences, or related field; or Bachelor's degree in life sciences, or related field, and 2 years of relevant experience as outlined in the essential duties in lieu of Master's degree.
- 2+ years of experience in the biotech industry.
- 2+ years of hands-on experience in molecular biology and biochemical techniques.
- Advanced knowledge of statistical and mathematical methods in biology/genetics, including experience with JMP software.
- Demonstrated understanding of IVD product manufacturing processes and biochemical, molecular, and real-time PCR Assays.
- Demonstrated ability to apply common laboratory skills and techniques; including a base knowledge in chemistry, biochemistry, molecular biology, or a related field.
- Authorization to work in the United States without sponsorship.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
Preferred Qualifications
- 2+ years of experience with medical device products in a technical or product support role.
- 2+ years of experience with Project Management principles and practice.
- 2+ years of experience with next-generation sequencing technology.
- Strong knowledge in design for Six Sigma and Statistics.
- Strong knowledge in basic and advanced continuous improvement methodologies/ principles such as LEAN Six Sigma and/or Practical Process Improvements (PPI).
If you need any assistance seeking a job opportunity at Exact Sciences, or if you may require a reasonable accommodation with the application process, please email hr@exactsciences.com.
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. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.