Summary of Major Responsibilities:
The Quality Control Next Generation Sequencing (NGS) Engineer will lead and provide technical expertise for transfer and implementation of QC methods and processes related to 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 and Responsibilities:
Lead or assist in the set-up of new laboratory equipment, inventory systems, procedures, and Quality Control processes for NGS workflows. Primary operator and technical resource for test method transfers and implementation of NGS related assays. Lead or assist in the scheduling, monitoring, and reporting of laboratory activities and lead project activities associated with Quality Control.Routinely perform techniques associated with complex molecular diagnostics and NGS workflows.Lead or participate in Out of Specification and customer complaint investigations, Deviation report generation and CAPA efforts. Execute protocols supporting Process and Test Method Validation efforts in accordance with internal procedures, cGMPs, FDA, and ICH guidelines.Write and review of quality documents, including but not limited to, Standard Operating Procedures and raw material specifications that are compliant with cGMP/GLP guidelines. Write training material and conducts training sessions on NGS activities.May provide leadership and mentor junior staff to resolve routine issues.Provide support in cross functional teams, as required.Support and comply with the company's safety and environmental procedures.Understanding and strong demonstration of DNA extraction, library preparation, sequencing techniques, and sequencing data analysis specifically with Illumina Next-Generation Sequencing (NGS) platforms.Experience with NGS lab automation and instrumentation, specifically for sample and library preparation workflows. Evidence of strong analytical and problem-solving skills, and ability to make decisions with limited information and operate with autonomy.Strong attention-to-detail necessary in a GMP environment.Proven ability to work effectively in team situations as well as independently.Able to organize, present, and convey complex problems or issues within and across other functions.Knowledge of statistical and mathematical methods in chemistry/biology.Ability to interface and work effectively within team and department, as well as all levels of the organization, vendors, customers, etc.Ability to effectively work on many complex and varied projects at one time, with frequent changing priorities and aggressive timelines. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the companys 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 seated for approximately 50% of a typical working day. Ability to work standing for approximately 05% of a typical working day.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 10% between local Exact Sciences Madison Redwood City locations.
Minimum QualificationsBachelors degree in Analytical or Applied Chemistry, Molecular Biology, Biochemistry or a field related to the essential duties of this role. 5+ years of experience with NGS in a setting related to the essential duties of this role.Strong knowledge of Microsoft Office programs, such as Word, Excel, and PowerPoint.Demonstrated ability to perform the essential duties of the position with or without accommodation. Authorization to work in the United States without sponsorship.Preferred QualificationsStrong documentation skills in accordance with GMP requirements.Familiarity with database, spreadsheets, and statistical programs.Experience in a GMP and/or ISO13485 environment.Experience and understanding in complex molecular biology or analytical chemistry techniques.
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 Companys affirmative action program are available to any applicant or employee for inspection upon request.