What are the responsibilities and job description for the Principal Scientist, Test Implementation and Launch, Technical Services position at Exact Sciences Careers?
100k tests / year volume.
- Develop or participate in publication strategies and overall technical communications within Exact.
- Report to Director audiences on launch progress, including identification and resolution of gaps, assessing and mitigating risks actively, directly and through influence to other departments.
- Provide business justification, lead, and manage improvements in processes and products with full accountability to ensure outcomes are in line with justification.
- Lead and guide other scientists in troubleshooting of customer issues through root cause investigation, experiment design, study execution, data analysis, and reporting.
- Directly or indirectly ensure effective representation of voice of the lab customer to cross-functional stakeholders including Development, Marketing, Finance, IT, and Quality for new products and revisions to existing products.
- Oversee and ensure quality and effectiveness of training program development for internal and external customers
- Contribute ideas or drive improvements to team processes.
- Assume responsibility for the quality and accuracy of all work products in Technical Services as well as the safety and accuracy of Exact's clinical tests.
- Ability to communicate clearly, frequently, and accurately in person, via the telephone, or by email.
- Ability to work independently.
- Apply advanced business and quality analysis tools.
- Apply strong communication and organizational skills.
- Ability to maintain confidentiality of sensitive information.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- Ability to work a designated schedule.
- 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 travel 35% of working time away from work location, may include overnight / weekend travel.
- Maintain regular and reliable attendance.
- Receive and document incoming customer communications.
- Work cooperatively with the technical services team and internal functional departments to troubleshoot and resolve customer questions or requests related to reagents, consumables, and assay issues.
- Support and comply with the company’s Quality Management System policies and procedures.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Minimum Qualifications
- Bachelor’s Degree in life sciences or related field.
- 10 years of experience in the life sciences or clinical diagnostics industry.
- 10 years of experience working in a molecular diagnostic or clinical laboratory, 5 years of experience leading new clinical test launches including validation, training, documentation, facility, and equipment readiness.
- Demonstrated leadership launching both in-vitro diagnostic (IVD) and laboratory-developed tests (LDTs) in a commercial clinical lab environment.
- Demonstrated advanced knowledge of clinical lab regulations such as College of American Pathologists (CAP), clinical laboratory improvement amendments (CLIA) or international equivalents.
- Proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, Outlook, Access, and OneNote.
- 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
- Advanced degree (Ph.D., M.S., etc.) in biology, chemistry, physics, engineering, or a related field.
- 15 years of experience in launching molecular diagnostic tests in many different laboratories.
- Successful launch of >
- Demonstrated proficiency in molecular biology techniques including Real-Time- polymerase chain reaction (PCR) Assays and next-generation sequencing.#LI-AN1Salary Range : $152,000.00 - $242,000.00 The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible, and is eligible to receive company stock upon hire as well as annually.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](https : / / careers.exactsciences.com / 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](mailto : neo@exactsciences.com?subject=Exact Sciences Recruiting).Not ready to apply? Join our [talent community](https : / / careers.exactsciences.com / talent-community) and stay up to date on what’s new at Exact Sciences.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.To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our [compliance hub](https : / / exactsciences.box.com / s / gj6pxvld7g6rnhvum3cttfdevppp34s2). The documents summarize important details of the law and provide key points that you have a right to know.
100 clinical diagnostic tests with a variety of IT systems, specimen collection structures (i.e. IOP, draw sites, mobile phlebotomy), commercial laboratory ordering and resulting by both electronic and paper means, analytical and clinical validation, FDA-approved, laboratory-developed, and New York State approved tests.
Salary : $152,000 - $242,000
