Senior Scientist, Microbiology

BD•Franklin Lakes, NJ

40d•Onsite

About The Position

We are the makers of possible 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. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. The R D team is seeking an exceptionally talented and passionate individual to help us identify and implement innovative solutions to address current and future health care needs. Within BD Medication Delivery Solutions (MDS) Research & Development, the Senior Scientist, Microbiology. will be part of the Materials Science team in Franklin Lakes NJ, reporting to the Associate Director, Materials Science. Our R D Engineers and Scientists are responsible for developing and implementing new product materials and designs, product improvements, and critical component changes for disposable and durable medical devices. The preferred candidate will have strong technical skills, excellent written and oral skills, and leadership abilities. This candidate should possess a strong capability to interpret and ensure compliance with all local, state, federal and BD safety regulations, quality policies, best practices, and procedures through appropriate communication. The Senior Scientist, Microbiology, plays a critical role in ensuring the microbiological integrity of products and processes throughout the development lifecycle. This position provides technical leadership in microbiology-related risk assessments, method development, and validation activities, supporting compliance with global regulatory requirements and internal quality standards. The role requires strong collaboration with cross-functional teams, including Platform Product R D, Regulatory Affairs, and Manufacturing, to deliver safe, effective, and innovative medical devices.

Requirements

Minimum bachelor's degree in microbiology or related field required, advanced degree preferred
Minimum 4 years of experience in microbiology within medical devices, pharmaceuticals, or related regulated industry.
Proven expertise in sterilization validation, bioburden control, and microbiological method development.
Research experience in microbiology, biochemistry or a related field that includes culturing and manipulation of microorganisms.
Experience in laboratory techniques in microbiology with demonstrated skills in adapting procedures to meet specific objectives and solve problems.
Strong knowledge of ISO 11737, ISO 11135, USP , , and related standards.
Understand and follow biosafety practices and use aseptic technique when working in microbiology labs.
Comprehensive knowledge of the medical device product development process under a quality management system in a regulated environment (ISO 13485, FDA cGMP/cGLP, etc)
Excellent analytical, problem-solving, and technical writing skills.
Ability to manage multiple priorities in a fast-paced environment.
Effective communicator and collaborator across functions and levels.

Responsibilities

Microbiological Risk Management: Lead microbiological risk assessments for new product development and sustaining projects. Define and implement contamination control strategies aligned with ISO 11737, ISO 11135, and related standards. Develop solutions to both unique and routine technical problems related to the assigned projects.
Method Development & Validation: Provide technical leadership for key aspects of development projects requiring the design and performing of microbiology experiments in the laboratory that includes culture of pathogenic bacteria and fungi, and handling of blood and blood products. Develop and validate microbiological test methods (bioburden, sterility, endotoxin, environmental monitoring). Ensure robustness and compliance of methods with USP, EP, and ISO requirements.
Sterilization & Cleanliness Support: Partner with sterilization engineers to establish and maintain validated sterilization processes. Support packaging integrity and EO residual testing strategies.
Regulatory & Quality Compliance: Author and review microbiology-related sections of regulatory submissions (510(k), CE marking, etc.). Ensure adherence to GMP, ISO 13485, and FDA QSR requirements.
Cross-Functional Collaboration: Provides experimental data and technical input to other scientists within R D and provides support to other functional groups in pursuit of project objectives. Serve as the microbiology SME in design reviews, hazard analyses, and CAPA investigations. Provide guidance to project teams on microbiological considerations impacting design and manufacturing.
Continuous Improvement: Identify opportunities to optimize microbiological testing efficiency and reliability. Mentor junior associates and contribute to knowledge-sharing initiatives.