As a Research Associate/Associate Engineer in Process & Product Development at Spear Bio, you will be responsible for developing and enhancing processes for our groundbreaking immunoassays and reagents. Your duties will include planning and executing characterization studies, drafting verification and validation protocols, performing IQ/OQ/PQ for new equipment, and collaborating with cross-functional teams to ensure quality and compliance with design requirements.

To qualify for the Research Associate/Associate Engineer role at Spear Bio, candidates should have a BS or MS in Bioengineering, Chemical Engineering, Biochemistry, Biology, or Chemistry, along with at least 1 year of relevant experience in product and process development or manufacturing support. Experience within the in-vitro diagnostics or biotech sectors and familiarity with statistical tools like DOE and process capability are highly beneficial.

In your role as a Research Associate/Associate Engineer at Spear Bio, you'll critically analyze existing processes and identify areas for enhancement. By performing technical reviews, risk assessments, and optimizations, you'll contribute to the continuous improvement of our product offerings, ensuring that we maintain our high standards of quality. This directly impacts our mission to provide superior diagnostic solutions.

At Spear Bio, you will be part of a fast-paced and innovative work environment where collaboration and knowledge sharing are highly valued. The team culture is built on mutual respect and the drive to revolutionize disease diagnostics, giving you the opportunity to contribute to meaningful advancements in healthcare.

Statistical analysis is crucial for a Research Associate/Associate Engineer at Spear Bio, as it informs the design and execution of our product characterization studies. Utilizing statistical tools such as Design of Experiments (DOE) ensures that our processes are scientifically sound and compliant with industry standards, enabling us to deliver high-quality assays efficiently.

In discussing your experience with process validation, be sure to highlight specific instances where you implemented protocols for IQ/OQ/PQ. Describe how you ensured compliance with quality standards and how your actions contributed to successful product launches.

When addressing your experience with DOE, give examples of experiments you designed and how the results impacted product development decisions. Emphasize your analytical skills and ability to draw actionable insights from data.

To effectively answer this question, choose a specific challenge related to immunoassay development or process improvements. Detail your approach to solving the problem, including the steps taken, tools used, and the successful outcome that followed.

Discuss your methodical approach to risk assessment, including identifying potential risks, evaluating their impact, and implementing mitigation strategies. Highlight any frameworks or tools you've used to structure your assessments.

Emphasize your understanding of regulatory standards such as FDA and ISO. Talk about specific experiences where you ensured compliance through diligent documentation, quality control practices, and collaboration with regulatory teams.

Illustrate your experience working in cross-functional teams by discussing a specific project. Highlight your communication skills and how you managed differing perspectives to achieve a shared objective.

Share your strategies for prioritization, such as using project management tools, regularly assessing project timelines, and maintaining clear communication with your team to adjust priorities as needed.

Talk about your systematic approach to troubleshooting, including identifying anomalies, hypothesizing potential causes, and implementing corrective actions. Provide an example of a successful troubleshooting experience.

Detail a specific instance where your contributions led to a measurable improvement in a process. Explain the changes you proposed, the rationale behind them, and the positive impact they had on operations.

Use this opportunity to convey your passion for innovative healthcare solutions. Articulate your alignment with Spear Bio's mission and how your skills can contribute to their exciting journey in revolutionizing early disease diagnostics.