Senior Scientist, Microbiology

Senior Scientist, Microbiology – BD Nogales Norte

The R&D team seeks an exceptionally talented individual to lead microbiological risk assessment, method development, and validation for BD Medication Delivery Solutions (MDS). The role supports clinical safety, regulatory compliance, and continuous improvement throughout the product lifecycle.

• Microbiological Risk Management
  • Lead 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 technical problems related to assigned projects.
• Method Development & Validation
  • Lead microbiology experiments on pathogenic bacteria, fungi, and blood products.
  • Develop and validate bioburden, sterility, endotoxin, and environmental monitoring methods.
  • Ensure compliance with USP, EP, and ISO requirements.
• Sterilization & Cleanliness Support
  • Collaborate 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, etc.).
  • Maintain adherence to GMP, ISO 13485, and FDA QSR requirements.
• Cross‑Functional Collaboration
  • Provide experimental data and technical input to other R&D scientists.
  • Serve as microbiology SME in design reviews, hazard analyses, and CAPA investigations.
  • Guide project teams on microbiological considerations for design and manufacturing.
• Continuous Improvement
  • Identify opportunities to optimize microbiological testing efficiency and reliability.
  • Mentor junior associates and share knowledge.

• Minimum bachelor’s degree in microbiology or related field; advanced degree preferred.
• Minimum 4 years of experience in microbiology within medical devices, pharmaceuticals, or regulated industry.
• Proven expertise in sterilization validation, bioburden control, and method development.
• Research experience with culturing and manipulating microorganisms.
• Proficiency in laboratory techniques and problem‑solving.
• Strong knowledge of ISO 11737, ISO 11135, USP, and related standards.
• Familiarity with biosafety practices and aseptic technique.
• Comprehensive understanding of the device development process under ISO 13485, FDA cGMP/cGLP.
• Excellent analytical, problem‑solving, and technical writing skills.
• Ability to manage multiple priorities in fast‑paced environments.
• Effective communicator and collaborator across functions and levels.

• Annual bonus
• Medical, dental, vision coverage
• Health Savings Accounts, Flexible Spending Accounts
• Hospital Care Insurance, Critical Illness, Accidental Injury, Life & AD&D insurance
• Short‑term and long‑term disability coverage
• Long‑term care with life insurance
• Health and well‑being programs:
  Anxiety management, Sleep improvement, Diabetes management, Substance use management, Wellness incentives, etc.
• Retirement benefits: 401(k) plan, Deferred Compensation, 529 College Savings
• Financial counseling, Daily Pay, College financial aid guidance
• Paid time off (PTO) including all state‑required leaves
• Educational assistance and tuition reimbursement
• Pet insurance, commuter benefits
• Support for adoption, eldercare, neurodivergent families, EAP, parental leave, fertility support
• Bereavement, military, personal, family and medical leave, jury duty leave

Location:

Franklin Lakes, NJ.

Employment type:

Full‑time. Seniority level:
Mid‑Senior. Salary range: $ – $ USD annually.

Becton, Dickinson, and Company 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, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.