Senior Scientist, Manufacturing & Quality Control

Exact Sciences Corporation
Atherton, CA
Closing date
May 21, 2022

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Science, Pharmaceutical, Quality Assurance
Organization Type
Summary of Major Responsibilities:
The Senior Scientist, Manufacturing and Quality Control role on the Manufacturing Sciences team will lead and coordinate a variety of Quality Control activities within Operations. This position will lead, plan, and perform routine quality control testing of raw materials, in-process materials, and finished goods. This position will lead and execute stability testing, process and method development and characterization, validation, and quality documentation generation. This position will lead and assist in process improvement and troubleshooting initiatives within quality control to drive performance and improve efficiency within the department, working closely with leadership and cross-functional teams. The Senior Scientist, Manufacturing and Quality Control is expected to possess an extensive understanding of laboratory procedures and conduct work within quality and regulatory guidelines.

Essential Duties and Responsibilities:
Plan and carry out quality control testing per defined procedures.Lead troubleshooting and investigations related to intermediate/complex equipment, testing, materials, and/or processes.Manage, develop, qualify, troubleshoot and may perform analytical and functional techniques associated with oligonucleotides, enzymes, antibodies, standard molecular biology reagents, and complex molecular diagnostics.Lead in the generation and timely execution of operator training schedules, ensuring alignment with the manufacturing and QC schedule. Perform classroom and on-the-job training of production staff.Ensure all documentation up-to-date to meet the Quality Manual System and regulatory requirements.Provide technical expertise and in-lab leadership for all personnel within the team to ensure the successful, effective, efficient, and safe preparation of quality finished goods.Acts as a Subject Matter Expert (SME) on core functions of the organization.Mentor, motivate, coach, and provide direction and clarity to other staff.Develop performance and productivity metrics to drive process improvements and ensure visibility to leadership and team. Support and lead Corrective and Preventive Action (CAPA) plans. Lead risk analyses activities; including design or Process Failure Mode and Effects Analysis (FMEA).Lead root cause analysis using recognized tools, such as Fault Tree Analysis or Fishbone Diagrams.Lead measurement system and test method development studies.Design basic method variability studies and execute basic measurement system analysis with support from SMEs or statisticians. Design stability studies for raw materials, intermediates, and finished goods.Apply tools to support continuous process improvement.Act as a lead resource and core team member for the Manufacturing Sciences and QC (MSQC) team to interface and collaborate with cross site departments (Quality Assurance (QA), Research & Development, Regulatory Affairs, Supply Chain, Engineering and the Clinical Lab) to achieve business results. Lead complex projects interfacing with one or two adjacent departments and regularly coordinate activities or lead sub-projects.Draft and review quality documents; including but not limited to, validation documentation, work instructions, Standard Operating Procedures (SOPs), and raw material specifications. Draft protocols supporting validation and stability studies in accordance with internal procedures, current Good Manufacturing Practices (GMP), and other standards and guidelines. Generate experimental protocols, inspection, and test methods procedures, and summarize development activities through technical summary reports.Lead and support equipment, process, and test method validation readiness and execution. Execute improvement opportunities for the Quality System. Generate and drive corrective action plans for more complex change orders, non-conformances, and other investigations. Determine timelines and consistently hit deliverables and commitments. Ability to generate plans, identify risk, and communicate to stakeholders.Ability to lead execution toward project milestones according to project timelines.Excellent verbal and written communication skills. Ability to organize, present, and convey complex problems or issues within and across other functions.Strong documentation skills and attention-to-detail necessary in regulated product development and manufacturing environment.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. Regular and reliable attendance. Ability to lift up to 30 pounds for approximately 2% of a typical working day.Ability to work seated for approximately 80% of a typical working day. Ability to work standing for approximately 20% 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 50% of a typical working day.Ability and means to travel between Redwood City campus locations.Ability to travel 5% of working time away from work location.#LI-AM1

Minimum QualificationsBachelor's degree in Chemistry, Biochemistry, Molecular Biology, Engineering, or related field.8+ years of experience in an industry laboratory setting.6+ years of experience working with biochemical and molecular assays. 3+ years working on in vitro diagnostic (IVD) manufacturing and quality control.3+ years of leadership or mentorship experience in quality control.Proficient in a variety of basic, intermediate, and advanced laboratory skills and techniques. Demonstrated ability to apply basic statistical techniques; including assessing data normality, control charting and data trending, hypothesis testing, assessing variation, basic linear regression, and model fitting. Demonstrated ability to use advanced techniques, such as Design of Experiments (DOE), Measurement System Analysis (MSA), and Multivariate Analysis of Variance (ANOVA).Demonstrated ability to apply recognized project management (PM) and scheduling tools, such as Microsoft Office Project. Proficient in Microsoft Office.Demonstrated ability to perform the Essential Duties of the position with or without accommodation. Authorization to work in the United States without sponsorship.Preferred Qualifications3+ years of direct leadership experience.Working knowledge of JMP or other statistical software tools.Working knowledge of Enterprise Resource Planning (ERP) systems and Bill of Materials (BOM) management.Working knowledge of continuous improvement approaches such as LEAN Six Sigma and/or Practical Process Improvement (PPI).Working knowledge of tools such as Process Flow and Value Stream Diagrams, Pareto Analysis, Control Charts, or Define, Measure, Analyze, Improve and Control (DMAIC).

EEO Disclosure:
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.

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