IVD Diagnostics: Process & Product Transfer Engineer

Spear Bio; Woburn (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Stock options

Competitive compensation

Great work environment

Comprehensive benefits

Job summary

Spear Bio Inc. in Massachusetts is seeking an Associate Engineer/Scientist for the Process & Product Transfer team to move new assays from development to manufacturing.

You will translate assay designs into manufacturing work instructions and support design transfer deliverables, ensuring documentation meets regulatory standards. The ideal candidate has hands-on experience in immunoassay development or manufacturing, knowledge of cGMP, and strong cross-functional collaboration skills.

Qualifications

• Bachelor’s or Master’s degree in a related field and required industry experience as specified.
• Experience in product or technology transfer within diagnostics and manufacturing environments.
• Knowledge of cGMP, FDA/ISO quality standards, and documentation practices.

Responsibilities

• Lead Product Transfer activities and ensure design transfer deliverables.
• Develop specifications and acceptance criteria for materials and processes.
• Translate assay designs into manufacturing instructions and batch records.
• Plan and execute process verification experiments to demonstrate robustness.

Skills

Attention to detail

Analytical thinking

Communication skills

Project management

Problem-solving

Excel proficiency

Education

Bachelor’s or Master’s degree in Bioengineering, Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or related field

3+ years (Bachelor’s) or 1+ years (Master’s) of relevant industry experience

Tools

AI tools for automation

Excel

Job description

Spear Bio Inc. in Massachusetts is seeking an Associate Engineer/Scientist for the Process & Product Transfer team to move new assays from development to manufacturing.

You will translate assay designs into manufacturing work instructions and support design transfer deliverables, ensuring documentation meets regulatory standards. The ideal candidate has hands-on experience in immunoassay development or manufacturing, knowledge of cGMP, and strong cross-functional collaboration skills.