Senior Manager Microbiology, Research and Product Development

Job Description

Job Description

Senior Manager Microbiology, Research, and Product Development

The Senior Manager Microbiology, Research has the ability to work in both existing and emerging topical anti-infective technologies and the ability to lead a microbiology group across other medical device applications. This role has responsibility for the scientific, operational and administrative oversight of the Microbiology Research Laboratories spread across two sites: R&D and Product Manufacturing. This position is actively involved in the product development team and is an individual who can push on timelines and answer technical questions, handle technical issues pertaining to medical device infection control product development.

The Senior Manager Microbiology will be responsible for providing a broad range of microbiology expertise to support the discovery and development of new antimicrobial products and to foster and facilitate support for existing products. The Senior Manager Microbiology will be responsible for ensuring technical accuracy and on-time delivery of results prioritized by the Infection Prevention Surgical business and other associated business units. The Senior Manager Microbiology will lead microbiological evaluation, development, and qualification of new antimicrobial technologies while leveraging microbiology and clinical expertise of the team and external thought leaders. This position will work closely with business, R&D, regulatory, quality, clinical and medical leaders and their teams from across the company in managing worldwide development programs.

This position is ultimately responsible for the overall microbiology package to support products and is the Subject Matter Expert in Microbiology

Qualifications:

• Ph.D. in life sciences (Microbiology preferred) or equivalent with a minimum of 8 years of industrial working experience in medical device or anti-infective Pharmaceutical product development

• MS in life sciences (Microbiology preferred) or equivalent with a minimum of 10 years of industrial working experience in medical device or anti-infective Pharmaceutical product development, or

• Bachelors life sciences (Microbiology preferred) or equivalent with a minimum of 12 years of industrial working experience in medical device or anti-infective Pharmaceutical product development

• and at least 5 years in technical managerial position

• 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 infection prevention pharmaceutical and/or medical devices.

Key Responsibilities:

• Accountability for planning, resource allocation and management, technical accuracy and on-time/on budget delivery of R&D Microbiology efforts to support GPDS and innovation based projects including Pre-Clinical and Clinical Microbiology and Quality based methodologies. Drives constant execution 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 other authorized bodies) and corporate/local 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.

• Is in the lab with the staff when needed but acting not only as the manager but primarily as the cross-functional subject matter expert (SME) across all of microbiology for the organization.

• Provides requested input on capital budgets, resource requirements, financial budgets during planning exercises. Simultaneously coordinates functional aspects of multiple 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 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 Interventional/Surgery business.

• Serves as an internal expert on technical matters related to current products, approaches, regulatory requirements, and clinical applications in the area of infection prevention approaches (pharmaceutical and/or device based).

• Represents the business in internal and external matters related to these topics when requested.

• Leads in strategic visioning, technical aspects of intellectual property and assessments of emerging internal and external technologies. 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.

• Maintains expertise in the field of clinical microbiology, and up-to-date knowledge of competitors, clinical needs, customer capabilities, and technical approaches.

• Participates in, and provides technical leadership for, multi-disciplinary technical projects in the Microbiology and Molecular area.

• Responsible for associate performance and 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 laboratory functionality, safety, training, equipment acquisition and maintenance, and space allocation.

• 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.

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