CHEManager International
Staff Scientist, Microbiology
CHEManager International, Franklin Lakes, New Jersey, us, 07417
Staff Scientist, Microbiology – Franklin Lakes, NJ
Company Overview : BD is one of the largest global medical technology companies. We advance health through innovative medical devices, products, and services and aim to transform the impossible into possibilities.
Job Summary : The Staff Scientist, Microbiology in the Materials Science team will lead microbiological risk management, method development, sterilization support, regulatory compliance, and cross‑functional collaboration to ensure microbiological integrity throughout product development.
Key Responsibilities
Microbiological Risk Management:
Lead risk assessments for new products and sustaining projects.
Define contamination control strategies per ISO 11737, ISO 11135, and related standards.
Develop solutions to routine and unique technical problems.
Method Development & Validation:
Provide technical leadership on microbiology experiments including culture of pathogens, fungi, blood, and blood products.
Develop and validate bioburden, sterility, endotoxin, and environmental monitoring tests.
Ensure methods meet USP, EP, and ISO requirements.
Sterilization & Cleanliness Support:
Partner with sterilization engineers to validate sterilization processes.
Support packaging integrity and EO residual testing strategies.
Regulatory & Quality Compliance:
Author and review microbiology 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 R&D and other functional groups.
Serve as SME in design reviews, hazard analyses, and CAPA investigations.
Guide teams on microbiological considerations impacting design and manufacturing.
Continuous Improvement:
Identify opportunities to improve testing efficiency and reliability.
Mentor junior associates and contribute to knowledge sharing.
Leadership
Lead cross‑functional governance for microbiology risk management and compliance.
Mentor senior scientists and engineers, building organizational capability.
Provide technical leadership for critical decisions, including supplier qualification, material selection, and new technology adoption.
Engage with regulatory agencies and notifies bodies; serve as BD’s microbiology SME during audits and inspections.
Represent BD in industry forums, standards committees, and external technical groups.
Qualifications
Bachelor’s degree in microbiology or related field required; advanced degree preferred.
Minimum 5 years’ experience in microbiology within medical devices, pharmaceuticals, or related regulated industry.
Proven expertise in sterilization validation, bioburden control, and microbiological method development.
Research experience involving culturing and manipulation of microorganisms.
Strong knowledge of ISO 11737, ISO 11135, USP, and related standards.
Ability to follow biosafety practices and aseptic technique.
Comprehensive knowledge of the medical device product development process under 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.
Benefits
Annual bonus potential.
Medical coverage, health savings accounts, flexible spending accounts, dental and vision coverage, hospital care insurance, critical illness insurance, accidental injury insurance, life and AD&D insurance, short‑term and long‑term disability coverage, long‑term care insurance.
Well‑being resources: anxiety management, wellness incentives, sleep improvement, diabetes management, virtual physical therapy, mental health programs, weight management, gastrointestinal health, substance use management, and specialized surgical benefits.
Retirement: 401(k), deferred compensation, 529 college savings, financial counseling, Daily Pay.
Life‑balance programs: PTO, educational assistance, legal plan, auto and home insurance, pet insurance, commuter benefits, discounts, scholarship, recognition awards, matching donation, workplace accommodations.
Other programs: adoption assistance, backup daycare, caregiver support, EAP, paid parental leave, fertility and birth support.
Leave programs: bereavement, military, personal, family and medical leave (FML), jury duty.
Salary USD 130,400.00 – 215,200.00 annually.
Additional Information Location: Franklin Lakes, NJ (USA).[+] 4 days in‑office per week required unless otherwise indicated. Vaccination requirements may apply.
Equal Opportunity Employer BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
#J-18808-Ljbffr
Job Summary : The Staff Scientist, Microbiology in the Materials Science team will lead microbiological risk management, method development, sterilization support, regulatory compliance, and cross‑functional collaboration to ensure microbiological integrity throughout product development.
Key Responsibilities
Microbiological Risk Management:
Lead risk assessments for new products and sustaining projects.
Define contamination control strategies per ISO 11737, ISO 11135, and related standards.
Develop solutions to routine and unique technical problems.
Method Development & Validation:
Provide technical leadership on microbiology experiments including culture of pathogens, fungi, blood, and blood products.
Develop and validate bioburden, sterility, endotoxin, and environmental monitoring tests.
Ensure methods meet USP, EP, and ISO requirements.
Sterilization & Cleanliness Support:
Partner with sterilization engineers to validate sterilization processes.
Support packaging integrity and EO residual testing strategies.
Regulatory & Quality Compliance:
Author and review microbiology 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 R&D and other functional groups.
Serve as SME in design reviews, hazard analyses, and CAPA investigations.
Guide teams on microbiological considerations impacting design and manufacturing.
Continuous Improvement:
Identify opportunities to improve testing efficiency and reliability.
Mentor junior associates and contribute to knowledge sharing.
Leadership
Lead cross‑functional governance for microbiology risk management and compliance.
Mentor senior scientists and engineers, building organizational capability.
Provide technical leadership for critical decisions, including supplier qualification, material selection, and new technology adoption.
Engage with regulatory agencies and notifies bodies; serve as BD’s microbiology SME during audits and inspections.
Represent BD in industry forums, standards committees, and external technical groups.
Qualifications
Bachelor’s degree in microbiology or related field required; advanced degree preferred.
Minimum 5 years’ experience in microbiology within medical devices, pharmaceuticals, or related regulated industry.
Proven expertise in sterilization validation, bioburden control, and microbiological method development.
Research experience involving culturing and manipulation of microorganisms.
Strong knowledge of ISO 11737, ISO 11135, USP, and related standards.
Ability to follow biosafety practices and aseptic technique.
Comprehensive knowledge of the medical device product development process under 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.
Benefits
Annual bonus potential.
Medical coverage, health savings accounts, flexible spending accounts, dental and vision coverage, hospital care insurance, critical illness insurance, accidental injury insurance, life and AD&D insurance, short‑term and long‑term disability coverage, long‑term care insurance.
Well‑being resources: anxiety management, wellness incentives, sleep improvement, diabetes management, virtual physical therapy, mental health programs, weight management, gastrointestinal health, substance use management, and specialized surgical benefits.
Retirement: 401(k), deferred compensation, 529 college savings, financial counseling, Daily Pay.
Life‑balance programs: PTO, educational assistance, legal plan, auto and home insurance, pet insurance, commuter benefits, discounts, scholarship, recognition awards, matching donation, workplace accommodations.
Other programs: adoption assistance, backup daycare, caregiver support, EAP, paid parental leave, fertility and birth support.
Leave programs: bereavement, military, personal, family and medical leave (FML), jury duty.
Salary USD 130,400.00 – 215,200.00 annually.
Additional Information Location: Franklin Lakes, NJ (USA).[+] 4 days in‑office per week required unless otherwise indicated. Vaccination requirements may apply.
Equal Opportunity Employer BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
#J-18808-Ljbffr