Associate Engineer/Scientist, Process & 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.

Spear Bio is seeking a dedicated and experienced Associate Engineer/Scientist, Process & Product Transfer to join our Product Transfer team. This role will support the transfer of new products from Assay Development to Manufacturing prior to commercialization, with responsibility for design transfer activities, process documentation, scaled reagent builds, and cross-functional execution. 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.

-Product Transfer

• Lead new product introduction (NPI) design transfer activities and ensure all required deliverables are completed in alignment with Product Development Process requirements.

• Develop specifications and acceptance criteria for raw materials or in-process materials to ensure product quality.

• Translate assay designs into manufacturing work instructions and in-process test instructions that can be easily understood by manufacturing operators.

• Build assay reagents at scale during feasibility and design verification phases while ensuring batch records are completed in accordance with cGMP requirements.

• Plan and execute process verification experiments to demonstrate the robustness and reproducibility of assays being transferred.

• Ensure material transactions are completed in a timely manner to maintain accurate inventory control.
  

-Compliance and Continuous Improvement

• Drive lean manufacturing, process improvement, and supply chain initiatives to improve cost of goods, efficiency, yield, and quality.

• Lead investigations during design transfer and provide resolutions for product and process issues.

• Develop electronic records for manufacturing work instructions and create data analysis templates to improve efficiency and reduce errors.

• Maintain detailed records of manufactured materials during the transfer process and complete batch records following cGMP requirements.

• Review executed batch records and work with QA to address any quality issues prior to release (deviation, NCMR, CAPA, change control).

• Ensure all process documentation is accurate, complete, and compliant with regulatory standards (e.g., FDA, ISO).

• Support regulatory submissions, audits, and inspections as required.

• Bachelor’s or Master's degree in Bioengineering, Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or a related field.

• If Bachelor’s degree, must also have 3+ years of relevant industry experience (see below). If Master’s degree, must also have 1+ years of relevant industry experience (see below).

• Relevant experience includes product or technology transfer, IVD or RUO diagnostic assay manufacturing, or manufacturing sciences in other regulated industry.

• 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.

• Familiarity with CLSI guidelines is a plus.

• 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.

• Experience leveraging AI tools to support process automation is a plus, with appropriate 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.