Process & Product Transfer Engineer - Biotech, Stock Ownership

Spear Bio Inc.; Woburn, Northern (MA, KY); Hybrid; USD 90,000 - 140,000; Full time

Benefits offered by this job

Stock ownership

Comprehensive benefits

Great work environment

Job summary

Spear Bio is seeking an Associate Engineer/Scientist, Process & Product Transfer to join our Product Transfer team in Woburn, MA. You will drive transfer of new products from Assay Development to Manufacturing, creating design transfer deliverables, and authoring manufacturing instructions.

The ideal candidate has hands-on immunoassay development or manufacturing experience in diagnostics, and a solid grasp of regulated product development and cGMP practices. This is a high-growth startup role.

Qualifications

• Bachelor’s or Master’s degree in a related field.
• 3+ years (Bachelor) or 1+ year (Master) of relevant industry experience.
• Experience with product or technology transfer in diagnostics.
• Experience with IVD or RUO diagnostic assay manufacturing.
• Familiarity with cGMP, FDA/ISO quality standards.

Responsibilities

• Lead NPI design transfer activities and deliverables.
• Develop specs and acceptance criteria for materials.
• Translate assay designs into manufacturing work instructions.
• Scale reagents and ensure batch records meet cGMP.
• Plan process verification experiments for robustness.
• Maintain inventory control and timely material transactions.
• Drive lean manufacturing and continuous improvement.
• Support regulatory submissions, audits, inspections.
• Investigate design transfer issues and provide resolutions.

Skills

Product transfer

cGMP

Regulatory compliance

Project management

Documentation practices

FDA/ISO knowledge

Analytical thinking

Cross-functional collaboration

Excel data analysis

AI tools in process automation

Education

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

Tools

Excel

Job description

Spear Bio is seeking an Associate Engineer/Scientist, Process & Product Transfer to join our Product Transfer team in Woburn, MA. You will drive transfer of new products from Assay Development to Manufacturing, creating design transfer deliverables, and authoring manufacturing instructions.

The ideal candidate has hands-on immunoassay development or manufacturing experience in diagnostics, and a solid grasp of regulated product development and cGMP practices. This is a high-growth startup role.