San Diego, California, United States
Onsite
Not Available
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At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.
Position Overview
The Senior Scientist, Assay Transfer role will lead a variety of design and test method transfer activities within Operations. This position is primarily responsible for leading or assisting the transfer and implementation of analytical and functional tests used to characterize and release products in operations. Additional responsibilities include collaboration with other departments to define test method requirements and development of new methods as needed.
Essential Duties
Include, but are not limited to, the following:
Provide design and test method transfer support to Operations by working cross-functionally with the Production, Quality Control, Supply Chain, R&D, Systems Development, and Quality teams.
Lead and support test method design and transfer via Test Method Transfer Forms/Plans, characterization studies, Method Development Reports, and quality Specification documents through collaboration, experiment design, study execution, data analysis, and reporting.
Lead and assist in training and knowledge transfer of test method development and execution.
Generate experimental protocols, draft test method procedures, characterize Test Methods, and summarize activities clearly and accurately through general reports.
Demonstrate proficiency in a variety of basic, intermediate, and advanced laboratory skills and techniques.
Program, operate, and troubleshoot complex instrumentation such as microplate readers, real-time and digital polymerase chain reaction (PCR) instruments, next-generation sequencers, and liquid handling automation.
Assist in development and characterization of complex functional and analytical test methods with general knowledge of their use in operations and QC.
Lead characterization of test method variability, design and coordinate execution of Measurement System Analysis (MSA) studies and determine specifications for simple to complex measurement systems.
Apply basic and advanced statistical techniques: assessing data normality, control charting and data trending, hypothesis testing, assessing variation, linear regression and model fitting, DOE, MSA, Multivariate Analysis, and ANOVA.
Analyze data to identify trends, assists/leads troubleshooting and root cause investigation efforts with ability to utilize recognized root cause analysis tools.
Assist and lead investigations into analytical and functional assays and associated equipment and during the transfer process of methods into operations.
Clearly and accurately generate experimental protocols, draft work instruction procedures, test methods, and summarize development activities through technical summary reports.
Support Process Validation and support/lead Test Method Validation readiness and execution. Provides support and review in generating Validation documentation.
Write new and edit existing Quality System documents (e.g. work instructions, standard operating procedures). Identify Continuous Improvement opportunities for the Quality System. Responsible for generating/driving corrective actions/action plans for more complex changes.
Collaborate with other departments (Quality Engineering, R&D, Regulatory Affairs, Supply Chain, Production, Validation, Quality Control) to achieve business results. Able to meet objectives without negatively impacting other functions.
Lead low to moderately complex projects. Generate project plans, identify risk, and communicate status to Operations Leadership. Lead team execution toward project milestones according to project timelines and apply recognized project management and scheduling tools.
Determine timelines and consistently hit deliverables and commitments.
Delegate, adapt, and demonstrate flexibility. Take calculated risks to exceed expectations. Renegotiate timelines with suggested path forward based business prioritization.
Function independently with limited guidance from supervisor as well as part of a team. Capable of leading teams to achieve business results. Proactive and forward thinking to plan and shift directions based on priorities/need.
Strong knowledge base in Molecular Biology, Biochemistry, Biotechnology, Chemistry, or a related field.
Strong understanding of in-vitro diagnostic product manufacturing processes and relevant assays (e.g. biochemical, RT-PCR, and NGS).
Excellent verbal and written communication skills.
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.
Act with an inclusion mindset and model these behaviors for the organization.
Ability to work nights and/or weekends, as needed.
Ability to travel 5% of working time away from work location, may include overnight/weekend travel.
Minimum Qualifications
Bachelor’s degree in life sciences or field related to the essential duties of the job.
6+ years of experience in the life sciences industry. Master’s or Doctoral degrees may be considered in lieu of 2 years of experience.
Proficient in MS Office Suite (Word, Excel, Outlook, PowerPoint).
2+ years working within an FDA 21 CFR 820, ISO 13485, ISO12207, and/or cGMP structured environment.
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
Proficiency with statistical analysis software and/or programing (e.g. JMP, R).
Advanced Degree in Biology, Chemistry, or similar discipline (MS, PhD).
Experience developing automated liquid handling workflows on Hamilton robotic platforms.
Experience with in-vitro diagnostic product development, design transfer, manufacturing, or product support.
Strong knowledge of continuous improvement methodologies/principles.
Familiarity with Project Management Principles and Practices.
Experience using Enterprise Resource Planning (ERP) software (SAP preferred).
Experience using Electronic Quality Management System (EQMS) software (Agile preferred).
Familiarity with CAP/CLIA regulatory requirements as they pertain to in vitro diagnostics.
Salary Range:
$90,000-$128,000
The annual base salary shown is for this position located in US - CA - San Diego on a full-time basis. In addition, this position is bonus eligible.
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 disability, protected veteran status, and any other status protected by applicable local, state, or federal law.
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. The documents summarize important details of the law and provide key points that you have a right to know.
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