Senior Scientist, Microbiology
- 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:
- Provides experimental data and technical input to other scientists within R&D and provides support to other functional groups in pursuit of 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 when working 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.
- Annual Bonus
- Medical coverage
- Health Savings Accounts
- Flexible Spending Accounts
- Dental coverage
- Vision coverage
- Hospital Care Insurance
- Critical Illness Insurance
- Accidental Injury Insurance
- Life and AD&D insurance
- Short-term disability coverage
- Long-term disability insurance
- Long-term care with life insurance
- Anxiety management program
- Wellness incentives
- Sleep improvement program
- Diabetes management program
- Virtual physical therapy
- Emotional/mental health support programs
- Weight management programs
- Gastrointestinal health program
- Substance use management program
- Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
- BD 401(k) Plan
- BD Deferred Compensation and Restoration Plan
- 529 College Savings Plan
- Financial counseling
- Baxter Credit Union (BCU)
- Daily Pay
- College financial aid and application guidance
- Paid time off (PTO), including all required State leaves
- Educational assistance/tuition reimbursement
- MetLife Legal Plan
- Group auto and home insurance
- Pet insurance
- Commuter benefits
- Discounts on products and services
- Academic Achievement Scholarship
- Service Recognition Awards
- Employer matching donation
- Workplace accommodations
- Adoption assistance
- Backup day care and eldercare
- Support for neurodivergent adults, children, and caregivers
- Caregiving assistance for elderly and special needs individuals
- Employee Assistance Program (EAP)
- Paid Parental Leave
- Support for fertility, birthing, postpartum, and age-related hormonal changes
- Bereavement leaves
- Military leave
- Personal leave
- Family and Medical Leave (FML)
- Jury and Witness Duty Leave
USA NJ - Franklin Lakes Additional Locations Work Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information
$106,600.00 - $175,900.00 USD Annual
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