Core IVD Tech Transfer Scientist

Thornton Tomasetti; Madison (WI); On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott is a global healthcare leader seeking a Core Scientist, Technical Transfer to drive design transfer into Operations for in vitro diagnostic manufacturing. You’ll develop new processes, document procedures, and implement transfer strategies in a regulated environment.

Responsibilities include scaling development batches, troubleshooting, validating processes, and ensuring quality systems compliance. Abbott offers strong benefits and opportunities for professional growth in Madison.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• 4 years of experience in biotech manufacturing or technical transfer.
• 4 years applying Chemistry, Biochemistry, or Molecular Biology 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) manufacturing processes and procedures per cGMP, ISO13485, and FDA guidelines.
• Assist execution of development batches per a defined build plan and troubleshoot issues.
• Develop and characterize moderately complex manufacturing processes.
• Execute process development pilot scale manufacturing for moderately complex processes/products.
• Support external design transfer of reagents to contract manufacturing operations.
• Support Process and Test Method Validation readiness and execution.
• Provide support and review in generating Validation documentation.
• Identify critical processing parameters and critical quality attributes.
• Assist and may lead root-cause investigations.
• Write new and edit existing Quality System documents.
• Identify continuous improvement opportunities for the Quality System.
• Drive corrective actions/change orders, SOPs, and manufacturing documentation.
• Develop training strategies for new manufacturing processes.
• Uphold company mission and values and comply with Quality Management System policies.
• Maintain regular attendance.

Skills

Biotech manufacturing

Chemistry/Biology in manufacturing

MS Office

US work authorization

Education

Bachelor's degree in Life Sciences or Engineering

Tools

SAP ERP

Job description

Abbott is a global healthcare leader seeking a Core Scientist, Technical Transfer to drive design transfer into Operations for in vitro diagnostic manufacturing. You’ll develop new processes, document procedures, and implement transfer strategies in a regulated environment.

Responsibilities include scaling development batches, troubleshooting, validating processes, and ensuring quality systems compliance. Abbott offers strong benefits and opportunities for professional growth in Madison.