Senior Manager, Research and Development
Summary of Responsibilities
The Senior Manager of R&D is the company- wide manager responsible for leading and overseeing all aspects of Product Development functions. The Senior Manager of R&D has overall responsibilities for project deliverables, quality, and budgets for the ongoing research programs. Design, develop, and execute multiple research and development projects, apply scientific knowledge to product development and product improvements. Manage the transfer of new services or IVD products to Manufacturing or Clinical Laboratory. Coordinate research grants and evaluation studies, create scientific publications. Support corporate-wide development objectives, provide technical guidance to Clinical Laboratory, Quality, Manufacturing, and IVD departments.
Essential Duties and Responsibilities
- Oversee the progress and execution of all R&D programs.
- Responsible for the supervision of Research and Development personnel.
- Provide leadership within the R&D department and across the organization.
- Work with cross-functional teams within the organization and gain alignment and move initiatives from product ideas to commercialization.
- Efficiently interact with staff in R&D, Clinical Services, Quality Control, Regulatory Affairs, and Manufacturing.
- Responsible for Research budget preparation and efficient use of resources.
- Responsible for communicating R&D needs, issues, developments with senior management.
- Oversight of research studies, research evaluation of potential new assays for development, and new generations of Laboratory Developed Tests.
- Responsible for oversight of laboratory safety procedures and annual safety training, Select Agent Program, CDC permits, etc.
- Conduct audits for outside key vendors.
- Write SOPs, research evaluation reports, QMS documents related to product development and functional quality assurance, publications, MSDS, etc.
- Extensive knowledge of state of the art immunological, cell culture, protein chracterization, antibody development techniques.
- Ability to supervise all levels of research staff.
- Ability to move seamlessly from strategic planning to tactical execution.
- Expertise in GLP, QMS, CLSI, CAP and other Clinical Laboratory and FDA regulated procedures.
- Demonstrate strong leadership ability and experience working collaboratively to meet the needs of internal departments and external clients.
- Possesses outstanding communication, interpersonal, problem solving and customer service skills.
- Strong organizational development, project management, analytical problem solving and troubleshooting skills.
Education and Experience
- Ph.D in life sciences, bacteriology, virology, genetics or other related discipline.
- Minimum ten years of in vitro diagnostic research and development experience with Clinical Laboratory or an IVD company. Immunoassay expertise required.
- At least seven years of proven experience in a leadership R&D position.
- Strong interpersonal and leadership skills.
Apply today for the Research and Development Scientist position at MiraVista Diagnostics in Indianapolis. Please use the form on the website Career Center (or email your resume to email@example.com if you have any problems with the web form).
MiraVista Diagnostics was established in 2002 and operates a fast-paced onsite clinical laboratory in Indianapolis where we process more than 100,000 diagnostic tests for serious fungal infections each year.