Spear Bio is a well-funded and rapidly growing start-up company based in Woburn, Massachusetts. We are focused on bringing to market a novel ultrasensitive immunoassay platform capable of utilizing small sample volumes with excellent data quality.
Spear Bio is looking for an experienced and motivated candidate to join our Product and Process Development team. The successful candidate will work to develop new processes or enhance existing ones for our Spear Bio immunoassay reagent manufacturing and testing. Thereafter the individual will characterize, verify, validate and implement new process to ensure high quality assays are manufactured to meet design requirements and customer expectations. He or She 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.
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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.
- 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.
- BS / BA in Bioengineering, Chemical Engineering, Biochemical Engineering, Biology or chemistry with 3+ years of relevant experience in product and process development or manufacturing support role
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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.