This job is archived
(Archived) Senior Scientist
Job Description
POSITION SUMMARY
The successful candidate will be working in a fast paced, agile, fast growing diagnostic product development organization. The candidate will be part of a global Assay (reagent) Development team located in Union City, California. The candidate will be responsible for supervising a team of 1-3 direct reports involved in various diagnostic R&D projects utilizing state-of-the-art technologies. The candidate will also have the opportunity to lead product development projects, managing cross functional teams to deliver quality products on time. The role has a strong focus on people leadership in a highly technical environment, and requires the ability to balance project needs with team and business needs.
The successful candidate provides timely communications to teams and management on project progress.
The candidate will be part of a Assay Lead team. The Assay Lead team is 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 Union City, California, the global development team is located in MI, NC and Copenhagen, Denmark. The role offers ample opportunities to operate globally and build lasting and effective relationship across sites.
POSITION RESPONSIBILITIES
The Pr. Sc. / S. Pr. Sc. has a wide and far reaching variety of responsibilities, including:
- 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
- Leading technical teams in diagnostic assay development activities with strong focus on product quality
- 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 direct reports and project teams in line with company values and culture
- Executing experimental studies bench-side with strong attention to details and high integrity in execution
- Executing complex data analysis
EDUCATION AND EXPERIENCE
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 thoughout 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 activites, post launch product maintenance.
- Extensive people and team leadership experience, leading direct reports and projects in line with company values and culture
- 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 managing people and projects
- Strong communication skills, working across functions and globally
- A solid technical understanding of chemistry, antibody and / or Molecular assay designs
- Preferred experience with antibody/antigen/ nanoparticle conjugation techniques, metabolite chemistry, microfluidics or molecular technologies
- 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