Scientist, Product Transfer

The role

You will lead the transfer of New Product Introductions from Assay Development to Manufacturing. You will partner with Assay and Process Development to ensure qPCR-based reagents and processes are robust, reproducible, and scalable.

What you will do

• Lead NPI design transfer and complete all Product Development Process requirements.
• Partner with Assay and Process Development to define assay requirements and design specifications.
• Set specifications and acceptance criteria for raw materials and in-process materials.
• Characterize and optimize qPCR performance and reduce variability.
• Establish contamination-control workflows for nucleic-acid reagent manufacturing.
• Translate assay designs into clear manufacturing and in-process test instructions.
• Build reagents at scale for feasibility and design verification, completing batch records per cGMP.
• Plan and execute process verification, including functional qPCR testing against reference lots.
• Complete material transactions promptly for accurate inventory control.
• Mentor and train junior team members.

Required qualifications

• Master’s degree with 3–5 years of industry experience, or Ph.D. with 1+ years of industry experience in Molecular Biology, Bioengineering, Chemical or Biochemical Engineering, Chemistry, Biochemistry,
• Molecular diagnostics/qPCR assay development and transfer of IVD/RUO assays in a regulated industry.
• Hands-on qPCR or molecular diagnostic assay development, optimization, and troubleshooting.
• Experience with real-time PCR instruments and software and interpreting amplification data.
• Knowledge of nucleic-acid reagent quality and stability.
• Experience with product/technology transfer and IVD or RUO molecular assay kit manufacturing under cGMP.
• Experience with process validation, statistics (including DOE), and continuous improvement.
• Demonstrated project management skills.
• Familiarity with design controls, Good Documentation Practices, cGMP, and FDA/ISO quality standards for medical device and IVD products.
• Strong attention to detail, analytical and problem-solving skills, and cross-functional communication.
• Proficiency in Excel for manufacturing records and data analysis templates.

Nice to have

• Immunoassay experience
• Familiarity with CLSI guidelines (e.g., EP and MM series)
• immunoassays (e.g., ELISA, proximity- or bead-based)
• AI tools for process automation with human-in-the-loop oversight

Benefits

• Competitive compensation
• Meaningful stock ownership
• Comprehensive benefits

About the company

Spear Bio, founded in 2021, is a well-funded and rapidly growing biotech start-up headquartered in Woburn, Massachusetts. Their proprietary technology, Successive Proximity Extension Amplification Reaction (SPEAR), is a novel wash-free immunoassay platform.