Associate Engineer/Scientist, Process & Product Transfer
$95,000–$95,000 year
On-siteWoburn, Massachusetts, United States
Job Summary
Lead new product introduction design transfer activities, translating assay designs into manufacturing work instructions and building scaled reagent builds while ensuring batch records comply with cGMP requirements. Develop specifications for raw materials, execute process verification experiments to demonstrate robustness, and drive lean manufacturing initiatives to improve yield and quality. Maintain detailed manufacturing records, review executed batch records with QA to address deviations, and support regulatory submissions and audits. This role bridges Assay Development and Manufacturing prior to commercialization within Spear Bio's R&D team, leveraging proprietary SPEAR technology to revolutionize early disease diagnosis.
Required Qualifications
- Bachelor's or Master's degree in Bioengineering, Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or a related field
- 3+ years of relevant industry experience (if Bachelor's degree)
- 1+ years of relevant industry experience (if Master's degree)
- 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
- Excellent communication skills to effectively collaborate with cross-functional teams
- Proficiency in Excel for creating manufacturing records and data analysis templates
Desired Qualifications
- Familiarity with CLSI guidelines is a plus
- Experience leveraging AI tools to support process automation is a plus, with appropriate human-in-the-loop oversight
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