Spear Bio Inc.
Research Associate/Associate Engineer, Process & Product Development
Spear Bio Inc., Woburn, Massachusetts, us, 01813
Research Associate/Associate Engineer, Process & Product Development
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. We are looking for an experienced and motivated candidate to join our Process & Product Development team. The successful candidate will work to develop new processes or enhance existing ones for our Spear Bio immunoassay and reagent manufacturing and testing. You will characterize, verify, validate, and implement new processes to ensure high-quality assays are manufactured to meet design requirements and customer expectations. You will work cross-functionally to execute studies, apply knowledge of laboratory techniques and statistical tools, and transfer new products into a regulated, high-throughput environment. Responsibilities:
Plan and execute immunoassay product and process characterization studies using statistical analysis and Design of Experiments (DOE) Draft and execute immunoassay product and process verification and validation protocol and reports Perform IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) for new manufacturing equipment Identify and implement product and process improvements by performing technical reviews, risk assessment, process optimization, and effectiveness checks Author root cause investigations and change control requests Collaborate with Platform and Assay Development members to transition development protocols into production, including validation experiments, automation, and SOP development. Qualifications:
Work experience in reagent/consumables production and product development Experience with applying statistical tools including DOE, process capability, and Statistical Process Control is a plus Excellent interpersonal skills and ability to function in a team environment are essential Possess the ability to learn and master complicated concepts quickly and comfortably Strong work ethic, with the ability to generate high-quality output in a fast-paced and ever-changing environment Familiarity with the application of FDA and/or ISO quality standards in a government-regulated industry for Medical Device Reagent and Assay preparation is a plus. Education/Experience:
BS or MS in Bioengineering, Chemical Engineering, Biochemical Engineering, Biology, or Chemistry with 1+ years of relevant experience in product and process development or manufacturing support role. 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 race, creed, color, religion, national origin, sex, sexual orientation, gender identity, age, or physical/mental disability.
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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. We are looking for an experienced and motivated candidate to join our Process & Product Development team. The successful candidate will work to develop new processes or enhance existing ones for our Spear Bio immunoassay and reagent manufacturing and testing. You will characterize, verify, validate, and implement new processes to ensure high-quality assays are manufactured to meet design requirements and customer expectations. You will work cross-functionally to execute studies, apply knowledge of laboratory techniques and statistical tools, and transfer new products into a regulated, high-throughput environment. Responsibilities:
Plan and execute immunoassay product and process characterization studies using statistical analysis and Design of Experiments (DOE) Draft and execute immunoassay product and process verification and validation protocol and reports Perform IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) for new manufacturing equipment Identify and implement product and process improvements by performing technical reviews, risk assessment, process optimization, and effectiveness checks Author root cause investigations and change control requests Collaborate with Platform and Assay Development members to transition development protocols into production, including validation experiments, automation, and SOP development. Qualifications:
Work experience in reagent/consumables production and product development Experience with applying statistical tools including DOE, process capability, and Statistical Process Control is a plus Excellent interpersonal skills and ability to function in a team environment are essential Possess the ability to learn and master complicated concepts quickly and comfortably Strong work ethic, with the ability to generate high-quality output in a fast-paced and ever-changing environment Familiarity with the application of FDA and/or ISO quality standards in a government-regulated industry for Medical Device Reagent and Assay preparation is a plus. Education/Experience:
BS or MS in Bioengineering, Chemical Engineering, Biochemical Engineering, Biology, or Chemistry with 1+ years of relevant experience in product and process development or manufacturing support role. 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 race, creed, color, religion, national origin, sex, sexual orientation, gender identity, age, or physical/mental disability.
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