BD (Becton, Dickinson and Company) Director R&D, Microbiology in Sparks, Maryland
Job Description SummaryReporting to the Sr. Director, Assays R&D, the Director R&D Microbiology has responsibilities for technical, administrative and personnel oversight of the Microbiology R&D function directed toward clinical microbiology, growth, identification and antibiotic sensitivity testing of pathogens. The leader shall provide functional excellence to assure technical accuracy and on-time delivery of programs sanctioned by the business, and support technology development and innovation efforts aimed at delivering novel, market-leading clinically actionable solutions. This position also has responsibility for generally leveraging the teams’ Microbiological expertise in support of other Diagnostic Systems programs, particularly the Microbiology Lab Automation and Molecular businesses, and contributing to the analysis and recommendations of strategic direction for current and future programs. The person in this role works closely with regulatory and medical functions in managing and implementing FDA, CLIA and other world-wide regulatory submissions and rulings, and serves as an R&D representative to these external regulatory bodies.
Working with minimal oversight, this associate is accountable for planning, resource allocation and management, technical accuracy and on-time/on budget delivery of R&D aspects of GPDS-based or sustaining programs in blood culture, TB culture, ID/AST, Core Clinical Microbiology and Lab Automation. Drives constant executional and process improvements, and strives to implement best-in-class operating approaches that maximize team functional deliverables. Incorporates compliance considerations with all the applicable regulatory agencies (FDA, ISO) and corporate policies (GPDS, QA) into program design and execution. Assures that the development and delivery of products are consistent with corporate standards and meets the requirement for performance and manufacturability. Provides requested input on capital budgets, resource requirements, financial budgets etc during planning exercises. Simultaneously coordinates functional aspects of multiple highly-complex programs comprising a diversity of technical, regulatory and business considerations wherein failure to successfully achieve the expected outcome will significantly impact critical business objectives.
Responsible for technical support and sustaining of current products as requested by the business. Responsible for providing requested Blood culture, TB culture, ID/AST and Core Microbiology functional input and support to sales, marketing, regulatory, medical and other functions. Responsible for documentation and maintenance of the microbiology culture collection and other resources that support the Infectious Disease diagnostics business as requested.
Serves as an internal expert on technical matters related to current products, approaches, regulatory requirements, and clinical applications in the area of Blood culture, TB culture, Core Clinical Microbiology, and ID/AST. Represents the business in internal and external matters related to these topics when requested. Significantly contributes to opportunity assessment, strategic visioning, technical aspects of intellectual property, and technology assessment/diligence within the scope of the responsibility. Provides technical updates, opinions, and recommendations to the Leadership team as requested. Provides technical information on competitive products and analyzes/strengths/weaknesses of competing technologies to assist commercialization efforts.
Contributes significantly to long-range strategies and future concepts by overlaying a full appreciation of customer needs, workflow, and drivers with appropriate technical options. Maintains expertise in the field of clinical microbiology, and up-to date knowledge of competitors, clinical needs, customer capabilities and technical approaches. Works closely with the marketing function in development and validation (e.g., voice of customer) of concepts and specifications leading to world-class solutions. Participates in, and provides technical leadership for, multi-disciplinary technical projects in the Microbiology and Molecular area.
Responsible for associate performance, HRP reviews, associate development and engagement, hiring, and adjusting the staff to meet business needs. Responsible for maintaining appropriate technical and knowledge skill sets within the team to provide support to the clinical, regulatory, marketing, sales and bench-based product development and technology development requirements of the programs. Responsible for succession planning of self and key associates.
The incumbent attends and represents the business at conferences and meetings. Contributes and drives publications, posters, seminars and other efforts that lead to establishment of the business as an innovative leader in the field. Establishes and manages high-value collaborations and partnerships to expedite business objectives in the area of responsibility.
Responsible for laboratory functionality, safety, training, equipment acquisition and maintenance, and space allocation. Works with facilities when required.
Responsible for implementation of experimental design and data documentation processes. Ensures the accurate recording of data that lead to and support decisions affecting product development, technology development or intellectual property. Contributes to intellectual property submissions and assures appropriate records in support of concepts and reduction to practice.
Education and experience
Requires a PhD in life sciences or equivalent with a minimal 12 years of industrial working experience on research and IVD product development, including at least 5 years in management. The successful candidate will have a proven record demonstrating all aspects of product design and development transfer to manufacturing, support of the regulatory and clinical submission process, and commercial launch of in vitro diagnostic assays in the global or regional marketplace.
Primary Work LocationUSA MD - Baltimore
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status