Principal Scientist-Immunoassay Diagnostics
The successful candidate will be working in a fast paced, fast growing diagnostic product development organization. The candidate will be part of a global Assay (reagent) Development team located in Kalamazoo, Michigan. The candidate will have the opportunity to lead product development projects, managing cross functional teams to deliver quality products on time utilizing state-of-the-art technologies. The role has a strong focus on leading through influence in a highly technical environment and requires the ability to balance project needs with team and business needs.
The candidate will contribute to the Immunoassay research and development team, in part responsible for maintaining best work practices, team-wide communications, resource alignment and project timeline reviews. The candidate will also be involved in facilitating assay team meetings, technical reviews, and global meetings.
The position offers a blend of leadership and technical excellence, and the candidate will be managing tasks bench-side as well as organizational. While the immediate interactions are located in Kalamazoo, MI the global development team is located in CA, NC and Copenhagen, Denmark. The role offers ample opportunities to operate globally and build lasting and effective relationship across sites.
This role has a wide variety of responsibilities, including:
EDUCATION AND EXPERIENCE
- Advising on experimental studies bench-side with strong attention to details and high integrity in execution
- Executing complex data analysis
- Leading diagnostic reagent (assay) research and development projects from product conception to launch in line with international standards and Quality Management systems
- Leading technical teams in diagnostic assay development activities with strong focus on product quality
- Leading cross functional teams through the entire product life cycle
- Providing timely communication on project progress to team, peers and management
- Driving diverse development teams to data-based and high-quality product decisions
- Providing day-to-day leadership and guidance to team members in line with company values and culture
B.S. / M. Sc in Chemistry, Biochemistry or Molecular Biology. Minimum of 5-8 years demonstrated assay research and development experience in a complex product environment. 3 years of team leader experience. Quality Management System understanding a must.
PhD in Chemistry, Biochemistry or Molecular Biology. Minimum of 5 years of demonstrated assay development experience in a complex product environment. 3 years of team leader experience. Quality Management System understanding a must.TECHNICAL SKILLS REQUIREMENTS
- Experienced in all phases of product development throughout product life cycle; conceptual and experimental study designs, root causing, reagent optimization, Verification and Validation, integration of assays onto medical devices / instrument platforms, reagent transfer activities, post launch product maintenance.
- Experience working in and leading cross functional teams including but not limited to: HW, SW, IT, manufacturing, Regulatory Affairs, Quality Assurance, QM, documentation management
- Strong organizational skills both in technical study designs and in influencing people and projects
- Strong communication skills, working across functions and globally
- A solid technical understanding of chemistry, biochemistry, and/or antibody assay designs
- Preferred experience with antibody/antigen/ nanoparticle conjugation techniques, metabolite chemistry and/or microfluidics
- Executing data analysis execution of experimental studies bench-side with strong attention to details and high integrity in execution using common analysis tools (jmp, alteryx, python, others)
- Strong understanding of Quality Management Systems
- Preferred experience managing post launch product development
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