The Manager, Reagent Systems is responsible for development and post launch support of the reagent assays for clinical Flow Cytometry systems.
Primary duties include the following:
- Manage the Reagent Systems team. Responsible for building and leading a coordinated and collaborative R&D team to facilitate efficient resource utilization and flexibility to respond to business growth opportunities.
- Maintain strong understanding of state-of-the-art science and technology development in the industry.
- Participate in clinical product development programs for the effective introduction of new products, consistent with the strategic plan.
- Lead the team to perform benchmarking studies with competitor assays and find improvement opportunities.
- Deliver clinical projects on schedule and within specification. Work with leadership team members and product development teams to improve time to market by reducing product development life cycle and improving the product development process.
- Prepare and oversee the preparation of technical reports, summaries, protocols, and analyses of R&D projects.
- Plan/participate in the sustaining projects, lead troubleshooting and risk assessment activities.
- Participate in interactions with regulatory agencies. Provide technical input into safety and regulatory interactions. Lead the team to provide R&D support of WW regulatory product registrations.
- Work on issues where analysis of situation or data requires review of relevant factors. Exercise judgment within defined procedures and policies to determine appropriate action.
- Effectively coordinate with other functional areas associated with the R&D activities, including Legal, Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs, Business Development, etc.
- Work with Quality on streamlining processes related to PIRs and CAPAs to reach a rapid and effective conclusion.
- Assure compliance with all local, state, federal, and BD policies/ procedures regulations associated with quality, regulatory, safety, HR, etc.
- Responsible for retaining, motivating and developing the associates to effectively fulfill the mission of R&D organization. Manage the talent pipeline to execute the R&D plan and provide effective leadership succession.
Education and Experience:
- Requires a Bachelor’s or higher degree in biological science and a combination of education and experience
- Minimum 5 years of demonstrated experience in R&D or clinical/research laboratory environment.
- Experience in IVD product development is required. Strong, proven product development knowledge of processes, measures, etc. (phase gated development systems)
- Knowledge of biostastisical methods and data analysis experience is required
- Experience with Flow Cytometry technology and experience in development of clinical Flow Cytometry assays and is highly desirable.
- Proven experience of working in cross-functional product development teams
- Six Sigma training/certification is desired
- Experience in creating efficient and productive R&D work environments: talent selection and developing high-performing R&D teams is beneficial.
- Strong relationship-builder, especially across functions.
- Ability to influence through effective communication,
- Rigorous scientific training and track record of publications, grants or patents.
- Will travel approximately 20% of the time.