Scientist, Product Transfer

Spear Bio, founded in 2021, is a well-funded and rapidly growing biotech start-up headquartered in Woburn, Massachusetts.  Our proprietary technology, Successive Proximity Extension Amplification Reaction (SPEAR), is a novel wash-free immunoassay platform, offering unprecedented sensitivity. We are dedicated to revolutionizing early disease diagnosis and monitoring by providing scalable, ultrasensitive solutions that deliver unparalleled accuracy in measuring low-abundant biomarkers, enabling clinicians and researchers to improve patient outcomes and advance global health.

Scientist, Product Transfer

We are seeking a Product Transfer Scientist with molecular diagnostics and qPCR assay development experience to join our Product Transfer team. You will lead the transfer of New Product Introductions (NPIs) from Assay Development to Manufacturing, partnering with Assay and Process Development to ensure our qPCR-based reagents and processes are robust, reproducible, and scalable. Immunoassay experience is a strong plus.

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.

Responsibilities:

-Product Transfer

• · Lead NPI design transfer and complete all 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 (e.g., oligonucleotides, enzymes, master mixes, antibodies, conjugates) and in-process materials.

  · Characterize and optimize qPCR performance (efficiency, linearity, LoD, precision) and reduce variability from inhibition, contamination, and reagent lot differences.

  · Establish contamination-control workflows for nucleic-acid reagent manufacturing (e.g., pre-/post-amplification separation, NTC monitoring, nuclease-free handling).

  · 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.
  

-Compliance and Continuous Improvement

• · Drive lean manufacturing and process improvements to improve COGS, efficiency, yield, and quality.

  · Lead investigations and root-cause analysis (e.g., Cq drift, 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.

Education & Experience:

• · Degree: 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, or a related field.

  · Field: Molecular diagnostics/qPCR assay development and transfer of IVD/RUO assays in a regulated industry.

Qualifications:

• · Hands-on qPCR or molecular diagnostic assay development, optimization, and troubleshooting (e.g., primer/probe design, cycling optimization, standard curves, inhibition, melt-curve analysis).

  · Experience with real-time PCR instruments and software (e.g., Bio-Rad CFX, QuantStudio, LightCycler) and interpreting amplification data.

  · Knowledge of nucleic-acid reagent quality and stability, including oligo QC, enzyme/master mix lot qualification, and contamination control.

  · 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.

  · Pluses: familiarity with CLSI guidelines (e.g., EP and MM series), immunoassays (e.g., ELISA, proximity- or bead-based), and AI tools for process automation with human-in-the-loop oversight.

We offer competitive compensation, meaningful stock ownership, comprehensive benefits, and a great work environment. This is an opportunity to enter an innovative, high-growth startup at an early stage and play an integral role in the company's growth and success. We are focused on identifying candidates who have demonstrated leadership and excellence throughout their careers and are excited by the prospect of building an industry-leading company.

Spear Bio Inc. provides equal opportunity in employment to all persons. No person shall be denied equal access because of race, creed, color, religion, national origin, sex, sexual orientation, gender identity, age, or physical/mental disability.

Spear Bio does not accept resume submissions from external recruiting agencies. Any unsolicited resumes or candidate information submitted without prior written agreement will be deemed the property of Spear Bio, and no placement fees will be paid.