BD Nogales Norte
Overview
Staff Scientist, Microbiology
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BD Nogales Norte BD is one of the largest global medical technology companies. The R&D team within BD Medication Delivery Solutions (MDS) Research & Development is seeking a Staff Scientist, Microbiology to be part of the Materials Science team in Franklin Lakes, NJ, reporting to the Associate Director, Materials Science. The role focuses on developing and implementing new product materials and designs, product improvements, and critical component changes for disposable and durable medical devices. The candidate should 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 works to ensure microbiological integrity throughout the development lifecycle and provides technical leadership in microbiology-related risk assessments, method development, and validation activities to support regulatory compliance and internal quality standards. Collaboration with cross-functional teams (Platform Product R&D, Regulatory Affairs, Manufacturing) is essential to deliver safe, effective, and innovative medical devices. 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, 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 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 pursue 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. Leadership Lead cross-functional technical governance for microbiology-related risk management and compliance, ensuring alignment with corporate and regulatory expectations. Mentor and coach senior scientists and engineers, building organizational capability in microbiology evaluations. Provide technical leadership for critical business decisions, including supplier qualification, material selection, and new technology adoption. Engage with regulatory agencies and notified bodies as BD’s microbiology subject matter expert during audits and inspections. Serve as global microbiology thought leader, representing BD in external technical forums, standards committees, and industry working groups. 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 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 For certain roles at BD, employment may depend on proof of full vaccination against COVID-19 where required by location, with accommodation requests considered under applicable law. Benefits
BD offers a competitive compensation package and a range of benefits including medical coverage, health savings accounts, flexible spending accounts, dental, vision, life and AD&D insurance, disability coverage, retirement plans, paid time off, and various wellness and work-life balance programs. Salary range information is provided where applicable: $130,400.00 - $215,200.00 USD annually.
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Staff Scientist, Microbiology
at
BD Nogales Norte BD is one of the largest global medical technology companies. The R&D team within BD Medication Delivery Solutions (MDS) Research & Development is seeking a Staff Scientist, Microbiology to be part of the Materials Science team in Franklin Lakes, NJ, reporting to the Associate Director, Materials Science. The role focuses on developing and implementing new product materials and designs, product improvements, and critical component changes for disposable and durable medical devices. The candidate should 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 works to ensure microbiological integrity throughout the development lifecycle and provides technical leadership in microbiology-related risk assessments, method development, and validation activities to support regulatory compliance and internal quality standards. Collaboration with cross-functional teams (Platform Product R&D, Regulatory Affairs, Manufacturing) is essential to deliver safe, effective, and innovative medical devices. 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, 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 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 pursue 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. Leadership Lead cross-functional technical governance for microbiology-related risk management and compliance, ensuring alignment with corporate and regulatory expectations. Mentor and coach senior scientists and engineers, building organizational capability in microbiology evaluations. Provide technical leadership for critical business decisions, including supplier qualification, material selection, and new technology adoption. Engage with regulatory agencies and notified bodies as BD’s microbiology subject matter expert during audits and inspections. Serve as global microbiology thought leader, representing BD in external technical forums, standards committees, and industry working groups. 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 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 For certain roles at BD, employment may depend on proof of full vaccination against COVID-19 where required by location, with accommodation requests considered under applicable law. Benefits
BD offers a competitive compensation package and a range of benefits including medical coverage, health savings accounts, flexible spending accounts, dental, vision, life and AD&D insurance, disability coverage, retirement plans, paid time off, and various wellness and work-life balance programs. Salary range information is provided where applicable: $130,400.00 - $215,200.00 USD annually.
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