Manufacturing & production jobs in Massachusetts

About the role

Spear Bio is seeking a dedicated and experienced Associate Engineer/Scientist, Process & Product Transfer to join our Product Transfer team. This role will support the transfer of new products from Assay Development to Manufacturing prior to commercialization, with responsibility for design transfer activities, process documentation, scaled reagent builds, and cross-functional execution. The ideal candidate will bring hands-on experience in immunoassay development or manufacturing within the diagnostics industry, along with a strong understanding of regulated product development and manufacturing practices.

What you'll bring

• Bachelor’s or Master's degree in Bioengineering, Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or a related field.
• If Bachelor’s degree, must also have 3+ years of relevant industry experience (see below).
• If Master’s degree, must also have 1+ years of relevant industry experience (see below).
• Relevant experience includes product or technology transfer, IVD or RUO diagnostic assay manufacturing, or manufacturing sciences in other regulated industry.
• Experience in product or technology transfer within the diagnostics industry under cGMP requirements to support product launches.
• Experience with IVD or RUO diagnostic assay kit manufacturing.
• Experience with process validation, statistical analysis, and continuous improvement methodologies.
• Demonstrated project management skills.
• Familiarity with design controls during the product development process.
• Familiarity with Good Documentation Practices, cGMP requirements, FDA and/or ISO quality standards for medical device and IVD products.
• High attention to detail to ensure accuracy and consistency in documentation and batch record execution.
• Strong analytical and problem-solving skills to address and resolve technical issues.