Locations Job Description Summary
Integrated Diagnostics Solutions (IDS) is seeking a R&D Staff Scientist Microbiologist, responsible for planning and performing bench experiments to support clinical microbiology product development projects. Reporting to the Group Manager, the successful candidate will be responsible for the design, development, integration and/or qualification of assays on automated systems. The successful candidate may also be expected to provide leadership in execution of clinical studies to validate performance of the assays and assemble relevant information in support of regulatory submissions.
Duties and Responsibilities:
- The successful candidate is responsible for providing technical leadership for key aspects of development projects requiring the design and performance microbiology experiments in the laboratory that includes culture of pathogenic bacteria and fungi, and handling of blood and blood products.
- Represents BD in collaborations with external KOLs, partners, current/prospective customers and/or vendors. May lead/direct drafting of publications, patent applications, or protocols for validations or clinical studies. etc.
- May formally supervise one or more associates.
- Appropriately delegate responsibilities to peers and junior associates in order to ensure efficiency
- Develops solutions to both unique and routine technical problems related to the assigned projects. Provides experimental data and technical input to other scientists within R&D and provides support to other functional groups in pursuit of project objectives. Can perform as a SME for technical reviews across the business segment.
- Provides mentorship and instruction to scientists and coordinates efforts to carry out experimental tasks. Is an effective teacher of product development, DFSS principles, data analysis/statistics, etc.
- Works closely with team members in the Growth Microbiology organization to developing new growth media formulations, supplementation or reagent configurations for automated microbiological systems.
- Understand and leverage published research in microbiology diagnostics.
- Minimum Bachelor's Degree in microbiology or related field required, advanced degree preferred
- Minimum of 7 years microbiology experience
- Research experience in microbiology, biochemistry or a related field that includes culturing and manipulation of microorganisms.
- Comprehensive knowledge of the medical device product development process under a quality management system in a regulated environment (ISO 13485, FDA cGMP/cGLP, etc)
- Experience in laboratory techniques in microbiology with demonstrated skills in adapting procedures to meet specific objectives and solve problems.
- Understand and follow biosafety practices and use aseptic technique when working in microbiology labs.
- Excellent verbal and written communication skills are necessary together with a history of self-motivation and work in a team environment.
- Experience working in a team oriented matrixed environment.
- Demonstrated skills in database use and statistical data analysis.
Primary Work LocationUSA MD - Baltimore