As an Engineer in Process & Product Development at Spear Bio, you will be responsible for developing and improving processes for our immunoassay reagent manufacturing. Key duties include planning and executing characterization studies, performing validation protocols, and working collaboratively with cross-functional teams to transition development protocols into production. Your expertise will be crucial in ensuring that our assays meet strict quality and design requirements.

To qualify for the Engineer, Process & Product Development role at Spear Bio, candidates should have a BS/BA in Bioengineering, Chemical Engineering, Biochemical Engineering, Biology, or Chemistry, along with at least 3 years of relevant experience in product and process development. Experience in the biotech or pharmaceutical industries is highly valued, particularly in areas related to in-vitro diagnostics and reagent production.

Statistical analysis is a cornerstone of the Engineer, Process & Product Development role at Spear Bio. You will be expected to apply statistical tools, including Design of Experiments (DOE) and Statistical Process Control, to ensure rigorous product characterization and process optimization. Your ability to leverage these techniques will help in driving improvements and maintaining the high standards of our immunoassays.

Spear Bio is committed to nurturing talent and providing opportunities for career advancement. As an Engineer in Process & Product Development, you'll have the chance to take on increasing responsibilities, lead projects, and collaborate with industry experts. With our focus on innovation and growth, you can expect pathways to advance your career and explore roles in leadership and specialized areas.

Discuss your relevant experience in process development, highlighting specific projects where you made significant contributions. Emphasize your understanding of immunoassay systems and your skills in implementing improvements in a high-throughput environment.

Mention specific statistical methods you've utilized, such as Design of Experiments (DOE) or Statistical Process Control. Provide examples of how your analytical skills have led to successful process optimizations or efficiencies in product development.

Illustrate your familiarity with FDA and ISO standards by referring to specific requirements you've adhered to in previous positions. Highlight your proactive approach to compliance and quality management throughout the development lifecycle.

Explain your approach to collaboration, including communication strategies and tools you utilize to ensure seamless teamwork. Share past experiences of successful cross-departmental projects and how you facilitated those efforts.

Select a specific example of a project challenge relating to process development and describe the steps you took to resolve it. Emphasize your problem-solving skills and ability to adapt in a fast-paced environment.

Discuss your methods for keeping current with the industry, such as attending conferences, reading scientific journals, or online courses. Show your enthusiasm for continued learning and relevance in your role.

Detail your systematic approach to process verification and validation, including the protocols you follow. Provide examples of how you've executed IQ/OQ/PQ in past roles and the outcomes of those processes.

Share strategies you employ to prioritize tasks and manage time effectively under tight deadlines while ensuring the highest quality standards. Include past experiences where you successfully met critical deadlines without compromising quality.

Highlight the importance of thorough documentation in process development. Talk about how you document experimental protocols, results, and compliance to support quality assurance and facilitate knowledge transfer.

Describe your conflict resolution techniques and how you would facilitate a productive discussion among team members. Emphasize the importance of understanding different perspectives and reaching a consensus focused on project goals.