Core Tech Transfer Scientist

Abbott Laboratories; Madison, Northern (WI, KY); Hybrid; USD 61,000 - 123,000; Full time

Job summary

Abbott Laboratories in Madison, WI is seeking a Core Scientist, Technical Transfer to lead and assist transfer of manufacturing processes for In Vitro Diagnostics, ensuring compliance with cGMP, ISO13485 and FDA guidelines.

You will develop, document, and implement new processes during design transfer, support development batches, troubleshoot issues, and help generate Validation documentation; strong collaboration with Operations is essential.

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 applying Chemistry, Biochemistry, or Molecular Biology principles in a manufacturing environment.
• Proficient in Microsoft Office Suite.
• Authorization to work in the United States without sponsorship.

Responsibilities

• 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.

Education

Bachelor’s degree in Life Sciences, Engineering, or a related field

Tools

Microsoft Office

SAP

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life.

You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

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.

What You’ll Work On

• 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.

Required 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 of 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.

The base pay for this position is $61,300.00 – $122,700.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Manufacturing DIVISION: ONCO Cancer Diagnostics LOCATION: United States > Madison : 650 Forward Dr ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Routine work with chemicals

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life-changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.