Senior Scientist, Microbiology

Overview

Senior Scientist, Microbiology at BD (Tissuemed Ltd)

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose. 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 Senior Scientist, Microbiology plays a critical role in ensuring the microbiological integrity of products and processes throughout the development lifecycle and provides technical leadership in microbiology-related risk assessments, method development, and validation activities, supporting compliance with global regulatory requirements and internal quality standards.

• 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:
  • Provide experimental data and technical input to other scientists within R&D and support other functional groups to achieve 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.

• 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 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

At BD, on-site collaboration is valued to foster creativity and effective problem-solving. Some roles require in-office presence; remote or field-based arrangements may be indicated in the posting. BD may require proof of vaccination for certain locations, with accommodation requests considered under applicable law. BD offers a competitive compensation package and benefits as described on the Careers Site.

Salary Range Information: $ - $ USD Annual