Manager, Quality Control - Sequencing

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Position Overview

The Manager, Quality Control (QC) - Sequencing will lead a team in a variety of QC functions including, but not limited to, raw material, in-process material, finished goods and stability testing, process and method development, characterization and validation, and quality document generation. This position will be responsible for scheduling actions and maintaining systems for QC functions. The position will lead and provide technical expertise for transfer and implementation of QC methods and processes related to next generation sequencing (NGS) applications. This position will work cross-functionally to establish QC workflows and data pipelines, train operators, and lead issue investigation through trending, troubleshooting, and root cause analysis. This role will also have responsibility for supporting Operations teams in method development, new product introduction, and continuous improvement efforts related to NGS assay platforms.

Essential Duties

Include, but are not limited to, the following:

• Lead the set-up of new laboratory equipment, inventory systems, procedures, and Quality Control processes for NGS workflows.
• Oversee and routinely perform techniques associated with complex molecular diagnostics and NGS workflows.
• Serve as a technical resource for test method transfers and implementation of Sequencing (NGS) related assays.
• Perform analytical and functional testing of raw materials, intermediates and finished goods in support of R&D, product and process characterization, the validation program, quality control, stability and troubleshooting efforts.
• Supervise, lead, develop, qualify, troubleshoot and routinely perform analytical and functional techniques associated with oligonucleotides, enzymes, antibodies, standard molecular biology reagents, and complex molecular diagnostics.
• Lead or assist in the scheduling, monitoring and reporting of laboratory activities.
• Utilize strong understanding of DNA extraction, library preparation, sequencing techniques, and sequencing data analysis (specifically with Illumina Next-Generation Sequencing (NGS) platforms) to troubleshoot, advise, improve or develop workflows .
• Lead design development and own the protocol generation, scheduling, and management of Stability studies.
• Provide subject matter expertise for the Quality Control processes in Out of Specification and NCMR resolution, Deviation report generation and CAPA efforts.
• Draft and/or review protocols supporting Process Validation, Test Method Validation, and Stability Studies in accordance with internal procedures, cGMPs, FDA, and ICH guidelines.
• Write and review quality documents including, but not limited to, Standard Operating Procedures and test and inspection methods that are compliant with cGMP/GLP guidelines.
• Provide representation or lead support of cross functional teams and process improvements.
• Lead project activities associated with or supported by QC.
• Serve as the primary certified trainer on all processes associated with core job function in which the individual is recognized as a SME. Develop new training modules and update current training modules as needed.
• Effectively manage, support, and guide your team including, but not limited to, delegating tasks and responsibilities, assessing employee performance and providing helpful feedback and training opportunities.
• Consistent demonstration of exceptional leadership qualities including, but not limited to, the ability to attract and retain the best team, foster a culture of high performance, lead with integrity, humility, accountability, and courage, and set a clear vision to energize teams towards the future.
• 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 designated schedule.
• Ability to work nights and/or weekends, as needed.
• 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 work seated for approximately 50% of a typical working day. Ability to work standing for approximately 50% of a typical working day.
• Ability to lift up to 50pounds 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 while performing repetitious actions.
• 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 10% between Exact Sciences locations and may include overnight/weekend travel away from home location.

Minimum Qualifications

• Bachelor's degree in chemistry, Molecular Biology or a science related field.
• 8+ years of experience using laboratory equipment and modern laboratory techniques in a Biotechnology field or clinical setting.
• 6+ years of experience with NGS technology in a setting related to the essential duties of this role.
• 2+ years of experience in a GMP/ ISO13485 laboratory environment and strong documentation skills in accordance with GMP requirements.
• 3+ years of leadership experience.
• Proficient in Microsoft Office, such as Word, Excel, PowerPoint, Outlook.
• Professional working knowledge with database, spreadsheets, and statistical programs.
• Professional knowledge of statistical and mathematical methods in biology/genetics.
• 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

• Direct leadership in a Quality Control environment.
• Strong understanding of sequencing data analysis.

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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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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