Associate Process Development Engineer or Scientist

Spear Bio - Woburn, MA

Full-time - Entry Level

Woburn, MA

About the position

The Associate Process Development Engineer or Scientist at Spear Bio will be responsible for developing and enhancing processes for immunoassay reagent manufacturing and testing. This role involves characterizing, verifying, validating, and implementing new processes to ensure high-quality assays meet design requirements and customer expectations. The successful candidate will work cross-functionally, applying laboratory techniques and statistical tools to support product development in a regulated, high-throughput environment.

Responsibilities

• Plan and execute immunoassay product and process characterization studies using statistical analysis and Design of Experiments (DOE)
• Draft and execute immunoassay product and process verification and validation protocol and reports
• Perform IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) for new manufacturing equipment
• Identify and implement product and process improvements by performing technical reviews, risk assessment, process optimization and effectiveness check
• Author root cause investigations and change control requests
• Collaborate with Platform and Assay Development members to transition development protocols into production, including validation experiments, automation, and SOP development.

Requirements

• Work experience in in-vitro diagnostics, biotech, life sciences, or pharmaceutical industries preferred
• Work experience in reagent/consumables production and product development
• Experience with applying statistical tools including DOE, process capability, and Statistical Process Control is a plus
• Excellent interpersonal skills and ability to function in a team environment are essential
• Possess an ability to learn and master complicated concepts quickly and comfortably
• Strong work ethic, the ability to generate high quality output in a fast-paced and ever-changing environment
• Familiarity with application of FDA and/or ISO quality standards in a government regulated industry for Medical Device Reagent and Assay preparation is a plus
• BS or MS in Bioengineering, Chemical Engineering, Biochemical Engineering, Biology or Chemistry with 1+ years of relevant experience in product and process development or manufacturing support role.

Nice-to-haves

• Experience with FDA and/or ISO quality standards
• Experience in a high-growth startup environment

Benefits

• Competitive compensation
• Meaningful stock ownership
• Strong benefits
• Great work environment