Research Associate/Associate Engineer, Product Transfer

Location: Woburn, Massachusetts
Department: Product Development
Employment Type: Full Time – Onsite
Minimum Experience: Entry-level

Spear Bio, founded in 2021, is a well-funded and rapidly growing 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 Associate Engineer or Research Associate to join our Product Transfer team. The successful individual will play a critical role in transferring New Product Introductions (NPIs) from Assay development to manufacturing, prior to commercialization. This includes building pilot or design verification reagent lots, drafting manufacturing work instructions and in-process test instructions, and building the bill of materials (BOM) for inventory control. The ideal candidate will have hands-on experience in product transfer or development and manufacturing processes within the diagnostic industry.

Responsibilities:

Product Transfer:

• Build pilot and design transfer lots of new assay products at scale to verify manufacturing processes, and ensure product performance and quality.
• Work with scientists and engineers to design and perform verification testing of early-stage reagents, to demonstrate robustness of assays being transferred.
• Support the drafting of manufacturing work instructions and in-process test instructions.
• Perform timely material transactions and participate in inventory control. Interface with other functional areas to ensure consistent supply of raw materials.
• Perform in-process testing methods to qualify in-process materials for downstream manufacturing.

Compliance and Continuous Improvements:

• Maintain detailed records of manufactured materials during the transfer process, and complete batch records following cGMP requirements.
• Participate in developing and optimizing processes to ensure consistent product quality.
• Ensure all process documentation is accurate, complete, and compliant with regulatory standards (e.g., FDA, ISO).

Qualifications:

• Bachelor’s degree in Bioengineering, Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or a related field.
• 1+ years of industry experience. Directly relevant Co-op / internship experience will be considered.  Experience should be in product/technology transfer, IVD/RUO diagnostic assay manufacturing (immunoassay or molecular diagnostics) in a regulated industry to support product launches.
• Familiarity with Good Documentation Practices and cGMP requirements.
• Strong analytical and problem-solving skills to address and resolve technical issues.
• Familiarity with FDA and/or ISO quality standards for IVD products a plus.
• Excellent communication skills to effectively collaborate with cross-functional teams.
• High attention to detail to ensure accuracy and consistency in documentation and batch record execution.
• Experience in either IVD or RUO diagnostic assay kit manufacturing.

We offer competitive compensation, with meaningful stock ownership, strong benefits, and a great work environment. This is an opportunity to enter an innovative, high-growth startup at an early stage. 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 blind 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.