Core Tech Transfer Scientist Exact Sciences Corporation
- 3.2 Madison, WI Job Details Full-time $76,000
- $125,000 a year 18 hours ago Benefits Paid parental leave Health insurance Dental insurance Paid time off Vision insurance Retirement plan Qualifications Quality control corrective actions Statistics Computer operation Hypothesis testing Phone communication Technical documentation ISO standards Design of manufacturing processes Engineering Corrective and preventive actions (CAPA) GMP Mid-level Statistical analysis Microscope proficiency Policy & process development Bachelor's degree in engineering Bachelor's degree Quality control documentation Continuous improvement Laboratory techniques Quality standards in production Pipetting Typing Productivity software Linear regression 1 year Root cause analysis SAP ERP Training Manufacturing company experience Molecular biology Editing FDA regulations Mobile devices Full Job Description Help us change lives 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 Core Scientist, Technical Transfer role will lead and assist a variety of technical transfer activities facilitating process and product transfer into Operations. This position will develop, document, and implement new processes and procedures as part of the design transfer process. Essential Duties Include, but are not limited to, the following: Support Operations in design and development of In Vitro Diagnostic (IVD) medical device manufacturing processes and procedures in accordance with cGMP, ISO13485, and FDA guidelines. Assists execution of development batches per a defined build plan, assists Production Operators in troubleshooting issues that arise during development manufacturing. Develops and characterizes moderately complex manufacturing processes incorporating industry standard techniques. Executes process development pilot scale manufacturing for moderately complex processes/products as well as more complex buffers. Supports external design transfer of reagents and/or components to contract manufacturing operations. Support Process and Test Method Validation readiness and execution. Provides support and review in generating Validation documentation. Supports identifying critical processing parameters and critical quality attributes. Assists and may lead troubleshooting and root cause investigation efforts with understanding of recognized tools. Write new and edit existing Quality System documents. Recognizes continuous improvement opportunities for the Quality System. Responsible for generating/driving corrective actions/action plans for more complex change requests/change orders, SOPs, work instruction, receiving inspection methods, and technical summary reports. Participates in identifying and developing manufacturing training strategy/techniques for new manufacturing processes. 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 on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% 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 80% of a typical working day. Ability to work standing for approximately 80% of a typical working day. Ability to lift up to 30 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 locations. Minimum Qualifications Bachelor's degree in Life Sciences, Engineering, or a related field. 4 years of experience in biotech manufacturing or technical transfer, within FDA regulated and/or
ISO13485
environments. 4 years of experience utilizing Chemistry, Biochemistry, or Molecular Biology principles in a manufacturing environment. Proficient in Microsoft Office Suite. 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 2 years experience applying statistical techniques including control charting, data trending, hypothesis testing, variation assessment, and basic linear regression. 1 year experience working within SAP enterprise resource planning.
Salary Range:
$76,000.00
- $125,000.00 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. 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. Not ready to apply? Join our Talent Community to stay updated on the latest news and opportunities at Exact Sciences. 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.
