Technical Transfer Scientist, IVD Manufacturing

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

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.