What are the responsibilities and job description for the Research Associate/Associate Engineer, Process & Product Development position at Spear Bio?
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 deliver unparalleled accuracy in measuring low-abundant biomarkers, enabling clinicians and researchers to improve patient outcomes and advance global health.
CLICK ON THIS LINK TO APPLY: https://spearbio.bamboohr.com/careers/50?source=aWQ9MzE=
Associate Scientist/Engineer, Process & Product Development:
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. Then, you will characterize, verify, validate and implement new processes to ensure high quality assays are manufactured to meet design requirements and customer expectations. They 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 check
- 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 in-vitro diagnostics, biotech, life sciences, or pharmaceutical industries preferred.
- Work experience in reagent/consumables production and product development
- Experience with apply statistical tools including DOE, process capability, and Statistical Process Control a plus
- Excellent interpersonal skills and ability to function in a team environment are essential
- Possess an 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 Reagent and Assay preparation 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
CLICK ON THIS LINK TO APPLY: https://spearbio.bamboohr.com/careers/50?source=aWQ9MzE=
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.
