Senior Engineer, Process & Product Development
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.
Senior Engineer, Process Development:
Spear Bio is looking for an experienced and motivated individual to join our Process & Product Development team. This individual will provide technical leadership for commercial immunoassay reagent 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:
Establish immunoassay reagent manufacturing process development and new product introduction requirements, and provide technical leadership to meet product specifications.
Translate technical requirements into defined and documentable manufacturing specifications and procedures.
Lead the optimization and scale-up of reagent manufacturing processes to achieve product launches 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 lead 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, 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. 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.
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Spear Bio is on the lookout for a dynamic Senior Engineer in Process & Product Development to join our innovative team in Woburn, Massachusetts. As a well-funded start-up, we are redefining early disease diagnosis with our cutting-edge Successive Proximity Extension Amplification Reaction (SPEAR) technology. If you’re passionate about pushing the envelope in biotech, this opportunity is for you! In this role, you will be at the forefront of our immunoassay reagent manufacturing, leading the charge in process development and new product introductions. Your ability to collaborate across teams—working closely with Manufacturing, R&D, and QA/RA—will be crucial to our success. Whether you're optimizing reagent manufacturing processes or developing precise testing methods for raw materials, your expertise will drive our projects forward. We’re looking for someone who thrives in a fast-paced environment, enjoys tackling complex technical challenges, and has a strong commitment to quality. With your background in bioengineering or a related field and at least 6 years of experience in process development or manufacturing support, you’ll become a go-to expert in our team. This is not just a job; it's a chance to make a significant impact while enjoying competitive compensation, meaningful stock ownership, and a supportive work environment. Join us and be a part of building a healthier world with Spear Bio!
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