Senior Engineer, Process & Product Development

Job Description Salary: About Spear Bio: 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 enable accurate measurement of low abundant biomarkers, and empowering clinicians and researchers to improve patient outcomes and advance global health. Senior Engineer, Process Development: Spear Bio is looking for an experienced and motivated individual to join our Process & Product Development team. As an expert in process development, this individual will provide technical leadership for commercial manufacturing process development, new product introduction, and technical support. This role requires a strong team player and implementor of change who will drive robust and scalable reagent manufacturing and testing processes. The successful individual will collaborate cross-functionally with Manufacturing, R&D, and QA/RA to achieve company and project goals. Responsibilities: Provide expert technical leadership in immunoassay reagent manufacturing process development and new product introduction. Establish reagent manufacturing process requirements to meet product specifications. Translate technical requirements into defined and documentable manufacturing specifications and procedures. Lead the development, optimization, and scale-up of reagent manufacturing processes to achieve target product launch and business goals. Solve challenging, interdisciplinary technical problems at the interface of biology, chemistry, engineering, and materials science. Develop test methods to assess raw material quality. Define, source, install, and qualify manufacturing equipment to support process and product volume requirements in collaboration with internal stakeholders and external suppliers. Independently design, develop, and execute experiments to justify technical decisions. Plan, develop, and coordinate multiple product and process development or manufacturing improvement projects with a high degree of creativity, foresight, and mature judgment. Become a subject matter expert in reagent manufacturing processes, including root cause investigations, validations, and others. Provide general guidance, career development, and training to junior level support staff. Qualifications: BS / BA in Bioengineering, Chemical Engineering, Biochemical Engineering, Biology or Chemistry with 6+ years of relevant work experience; or MS with 4+ years of relevant experience; or PhD with 2+ years of relevant experience: Direct experience in process development, or manufacturing support within in-vitro diagnostics, biotech, life sciences, or pharmaceutical industries

required . Experience with reagent/consumables production and product development, with successful oversight through end stage manufacturing and commercialization

required . Experience applying statistical tools including DOE, process capability, and Statistical Process Control. Excellent interpersonal skills and ability to function in a team environment. Advanced ability to learn and master complicated concepts quickly and comfortably. Strong work ethic, the ability to generate high quality output in a fast-paced and ever-changing environment. Familiarity with application of FDA and/or ISO quality standards in a government regulated industry for Medical Device Reagents and Assay preparation a plus. We offer competitive compensation, with meaningful stock ownership, strong benefits, and a great work environment. This is an opportunity to enter a high-growth startup company at an early stage. We are recruiting candidates who have demonstrated leadership and excellence throughout their careers and are excited by the prospect of- and the effort involved in- 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 creed, race, color, religion, sex, national origin, age, disability, or physical/mental condition.

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