Core Tech Transfer Scientist

Abbott (abbottcareers2 board); United States; On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Career development

Free medical coverage

Retirement savings plan

Tuition reimbursement

FreeU education benefit

Recognition as a great place to work

Job summary

Abbott is seeking a Core Scientist, Technical Transfer to lead and assist technical transfer activities for In Vitro Diagnostic (IVD) manufacturing. The role develops, documents, and implements new processes as part of the design transfer, ensuring compliance with cGMP, ISO13485, and FDA guidelines.

You will support development batches, troubleshoot issues, and contribute to pilot-scale process development, validation readiness, and documentation.

Qualifications

• Bachelor's degree required in Life Sciences, Engineering, or 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 manufacturing.

Responsibilities

• Support Operations in design and development of In Vitro Diagnostic (IVD) medical device manufacturing processes and procedures per cGMP, ISO13485, and FDA guidelines.
• Assists execution of development batches per a defined build plan and helps Production Operators troubleshoot during development manufacturing.
• Develops and characterizes moderately complex manufacturing processes using standard industry techniques.
• Executes pilot-scale process development for moderately complex processes/products and more complex buffers.
• Supports external design transfer of reagents and/or components to contract manufacturing operations.
• Supports Validation readiness and documentation, identifying critical processing parameters and critical quality attributes.

Education

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

Job description

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.

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.