Associate Director, Microbiology

Job description

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job DescriptionJob Summary The Associate Director, Microbiology provides strategic, scientific, and functional leadership for microbiology activities supporting the discovery, development, registration, commercialization, and lifecycle management of antimicrobial and infection-prevention products. The role is accountable for the technical accuracy, quality, compliance, prioritization, and timely delivery of microbiology programs conducted through internal and external resources. Operating with a high degree of independence and strategic ownership, the Associate Director defines and drives microbiology strategy across innovation and new product development portfolios. The role translates business, customer, clinical, regulatory, and manufacturing needs into executable scientific strategies; influences cross-functional and portfolio decisions; develops organizational capability; and advances novel, differentiated solutions through internal expertise, external partners, and scientific thought leaders. Job Responsibilities Define and independently drive the microbiology strategy for innovation and new product development programs from opportunity assessment and concept feasibility through design verification, validation, regulatory submission, launch, and lifecycle support. Provide strategic scientific leadership across a portfolio of innovation and product development programs, establishing priorities, decision criteria, technical milestones, resource plans, budgets, governance expectations, and risk-mitigation strategies. Create and maintain a forward-looking microbiology technology and capability roadmap aligned with business strategy, unmet clinical needs, market opportunities, and product portfolio priorities. Lead the microbiological evaluation, development, and qualification of new antimicrobial technologies, test methods, and product concepts that support differentiated and clinically relevant solutions. Ensure product development and delivery are consistent with corporate standards and meet applicable performance, quality, regulatory, manufacturability, and business requirements. Incorporate applicable global medical device and pharmaceutical regulations, quality-system requirements, standards, and corporate and local policies into program strategy, experimental design, execution, documentation, and decision-making. Act as a senior technical and functional decision-maker for complex microbiology issues, making sound recommendations with limited oversight and clearly communicating scientific rationale, risk, tradeoffs, and business impact to senior leadership. Represent Microbiology in portfolio governance, design and phase reviews, regulatory strategy discussions, and senior leadership reviews, ensuring decisions are supported by appropriate evidence and transparent assessment of technical and program risk. Influence product and portfolio direction through evidence-based recommendations and effective partnership with R&D, Marketing, Medical, Clinical, Regulatory, Quality, Manufacturing, Operations, Sales, and business leadership. Lead technical due diligence and microbiology assessments of external technologies, licensing opportunities, suppliers, acquisitions, strategic collaborations, and external testing partners, as applicable. Establish and manage high-value scientific collaborations and partnerships that accelerate business objectives and expand access to differentiated technologies and capabilities. Provide microbiology leadership and sustaining support for marketed products, product changes, investigations, regulatory commitments, and lifecycle-management activities. Author, review, and defend microbiology-related content in regulatory submissions and responses for products under development and on the market. Oversee laboratory strategy, priorities, safety, compliance, training, equipment and capability investments, culture collections, space planning, data integrity, and continuous improvement. Ensure robust experimental design, method development and qualification, data documentation, and scientific records that support product decisions, technology development, regulatory filings, and intellectual property. Build organizational capability through workforce planning, succession planning, hiring, performance management, coaching, mentoring, talent development, and establishment of scientific standards and communities of practice. Lead an accountable, inclusive, and high-performing organization; assess resource capacity and capability and adjust internal and external resources to meet current and future business needs. Anticipate emerging scientific, regulatory, competitive, and clinical trends and translate them into innovation priorities, capability investments, and product development strategies. Represent BD at scientific conferences, professional meetings, and external forums and support publications, posters, seminars, patents, and other activities that reinforce scientific leadership. Perform other duties as assigned by management. Education and Experience Master's Degree in Microbiology, or a related scientific discipline with a minimum of 10+ years of experience.PhD preferred. Progressively responsible experience in microbiology, antimicrobial product development, infection prevention, or a related regulated life-sciences field, with experience commensurate with the degree level and scope of an Associate Director role. Significant scientific experience, including accountability for innovation or new product development programs, cross-functional strategy, organizational capability, and proven track record of delivery of business-critical outcomes. Seasoned  people manager with proven track record of  successfully  leading, coaching, developing and mentoring talent. Experience within the pharmaceutical, medical device, or other regulated life-sciences industry. Experience working in development environments operating under applicable cGMP, GLP, ISO, and U.S. FDA quality-system requirements, including 21 CFR Parts 210/211 and 820, as relevant to the product portfolio. Required Qualifications Demonstrated expertise in microbiology and the ability to serve as a senior internal authority for antimicrobial products, technical approaches, regulatory requirements, development strategy, and clinical applications in infection prevention. Demonstrated leadership of innovation and new product development programs with accountability for technical strategy, execution, cross-functional alignment, risk management, and delivery of business-critical outcomes. Proven ability to work independently, navigate ambiguity, set strategic direction, and make high-quality scientific, organizational, and portfolio decisions without detailed day-to-day oversight. Demonstrated ability to translate business strategy, customer and clinical needs, regulatory expectations, and manufacturing considerations into coherent microbiology strategies and executable product development plans. Experience leading multiple complex programs or a portfolio of projects, including prioritization, governance, resource and budget planning, external partnerships, risk management, and management of competing business needs. Experience influencing senior leaders and cross-functional stakeholders through scientific credibility, clear recommendations, effective communication, and constructive challenge. Demonstrated ability to identify and resolve complex issues, communicate risks and recommendations transparently