Scientist, Product Transfer

Spear Bio•Woburn, MA

3d•$95,000 - $95,000

About The Position

Spear Bio is seeking a Product Transfer Scientist with molecular diagnostics and qPCR assay development experience to join its Product Transfer team. The role leads transfer of New Product Introductions from Assay Development to Manufacturing and partners with Assay and Process Development to ensure qPCR-based reagents and processes are robust, reproducible, and scalable. The position focuses on molecular diagnostic and qPCR assay development and transfer in a regulated industry; immunoassay experience is a strong plus. The successful candidate will bring hands-on experience in qPCR or molecular diagnostic assay development, optimization, and troubleshooting; experience transferring and manufacturing IVD or RUO assays; and an understanding of regulated product development and manufacturing practices. The role also supports compliance with FDA and ISO standards, regulatory submissions, audits, and inspections, while driving continuous improvement in manufacturing quality, efficiency, yield, and cost.

Requirements

Master’s degree with 3–5 years of industry experience, or Ph.D. with at least 1 year of industry experience, in Molecular Biology, Bioengineering, Chemical or Biochemical Engineering, Chemistry, Biochemistry, or a related field.
Experience in molecular diagnostics/qPCR assay development and transfer of IVD or RUO assays in a regulated industry.
Hands-on qPCR or molecular diagnostic assay development, optimization, and troubleshooting, including techniques such as primer/probe design, cycling optimization, standard curves, inhibition assessment, and melt-curve analysis.
Experience with real-time PCR instruments and software, such as Bio-Rad CFX, QuantStudio, or LightCycler, and interpretation of amplification data.
Knowledge of nucleic-acid reagent quality and stability, including oligo QC, enzyme/master mix lot qualification, and contamination control.
Experience with product or 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 Haves

Immunoassay experience, such as ELISA or proximity- or bead-based assays.
Familiarity with CLSI guidelines, including EP and MM series.
Familiarity with AI tools for process automation with human-in-the-loop oversight.

Responsibilities

Lead New Product Introduction design transfer and complete Product Development Process requirements.
Partner with Assay and Process Development to define assay requirements and design specifications, including oligonucleotide, enzyme, and master mix needs.
Set specifications and acceptance criteria for raw materials and in-process materials.
Characterize and optimize qPCR performance, including efficiency, linearity, limit of detection, and precision; reduce variability caused by inhibition, contamination, and reagent lot differences.
Establish contamination-control workflows for nucleic-acid reagent manufacturing, including pre-/post-amplification separation, NTC monitoring, and nuclease-free handling.
Translate assay designs into manufacturing and in-process test instructions.
Build reagents at scale for feasibility and design verification and complete batch records in accordance with cGMP.
Plan and execute process verification, including functional qPCR testing against reference lots.
Complete material transactions promptly to maintain accurate inventory control.
Mentor and train junior team members.
Drive lean manufacturing and process improvements to improve cost of goods sold, efficiency, yield, and quality.
Lead investigations and root-cause analyses, such as Cq drift and failed controls, and resolve product and process issues.
Develop electronic work instructions and data analysis templates to improve efficiency and reduce errors.
Review executed batch records and partner with QA on deviations, NCMRs, CAPAs, and change control before release.
Ensure documentation complies with FDA and ISO standards and support regulatory submissions, audits, and inspections.