BD (Tissuemed Ltd)
Overview
Staff Scientist, Microbiology at BD (Tissuemed Ltd). The R&D team in Franklin Lakes, NJ seeks an exceptionally talented and passionate individual to help identify and implement innovative microbiology solutions within the Materials Science team. Reporting to the Associate Director, Materials Science, this role supports development of new product materials and designs, product improvements, and critical component changes for disposable and durable medical devices. The ideal candidate will have strong technical skills, excellent written and oral communication, and leadership abilities, with the capability to interpret and ensure compliance with local, state, federal, and BD safety regulations, quality policies, and procedures. The Staff Scientist, Microbiology
plays a critical role in ensuring the microbiological integrity of products and processes throughout the development lifecycle, providing technical leadership in microbiology-related risk assessments, method development, and validation activities, and supporting compliance with global regulatory requirements and internal quality standards. This role requires collaboration with cross-functional teams, including Platform Product R&D, Regulatory Affairs, and Manufacturing. Key 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 assigned projects. Method Development & Validation: Provide technical leadership for microbiology experiments (including 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 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; serve as the microbiology SME in design reviews, hazard analyses, and CAPA investigations; guide 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. Leadership: Lead cross-functional technical governance for microbiology-related risk management and compliance; mentor and coach senior scientists and engineers; provide technical leadership for supplier qualification, material selection, and new technology adoption; engage with regulatory agencies during audits and inspections; represent BD as a microbiology thought leader in external forums. Qualifications
Minimum bachelor’s degree in microbiology or related field required; advanced degree preferred. Minimum 5 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 related field with culturing/manipulation of microorganisms. Experience in laboratory techniques in microbiology; ability to adapt procedures to meet objectives and solve problems. Strong knowledge of ISO 11737, ISO 11135, USP, EP, and related standards; biosafety practices and aseptic technique knowledge. Comprehensive knowledge of the medical device product development process under a quality management system (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 cross-functional collaborator. Note: The role may involve on-site collaboration requirements and compliance with BD vaccination and accommodation policies where applicable. For more information about BD, visit our careers site.
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Staff Scientist, Microbiology at BD (Tissuemed Ltd). The R&D team in Franklin Lakes, NJ seeks an exceptionally talented and passionate individual to help identify and implement innovative microbiology solutions within the Materials Science team. Reporting to the Associate Director, Materials Science, this role supports development of new product materials and designs, product improvements, and critical component changes for disposable and durable medical devices. The ideal candidate will have strong technical skills, excellent written and oral communication, and leadership abilities, with the capability to interpret and ensure compliance with local, state, federal, and BD safety regulations, quality policies, and procedures. The Staff Scientist, Microbiology
plays a critical role in ensuring the microbiological integrity of products and processes throughout the development lifecycle, providing technical leadership in microbiology-related risk assessments, method development, and validation activities, and supporting compliance with global regulatory requirements and internal quality standards. This role requires collaboration with cross-functional teams, including Platform Product R&D, Regulatory Affairs, and Manufacturing. Key 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 assigned projects. Method Development & Validation: Provide technical leadership for microbiology experiments (including 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 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; serve as the microbiology SME in design reviews, hazard analyses, and CAPA investigations; guide 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. Leadership: Lead cross-functional technical governance for microbiology-related risk management and compliance; mentor and coach senior scientists and engineers; provide technical leadership for supplier qualification, material selection, and new technology adoption; engage with regulatory agencies during audits and inspections; represent BD as a microbiology thought leader in external forums. Qualifications
Minimum bachelor’s degree in microbiology or related field required; advanced degree preferred. Minimum 5 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 related field with culturing/manipulation of microorganisms. Experience in laboratory techniques in microbiology; ability to adapt procedures to meet objectives and solve problems. Strong knowledge of ISO 11737, ISO 11135, USP, EP, and related standards; biosafety practices and aseptic technique knowledge. Comprehensive knowledge of the medical device product development process under a quality management system (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 cross-functional collaborator. Note: The role may involve on-site collaboration requirements and compliance with BD vaccination and accommodation policies where applicable. For more information about BD, visit our careers site.
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