CHEManager International · 23 hours ago
Senior Scientist, Microbiology
Franklin Lakes, NJ
Full-time
Onsite
Mid, Senior Level
$107K/yr - $176K/yr
4+ years expBD is one of the largest global medical technology companies in the world, and they are seeking a Senior Scientist in Microbiology to join their R&D team. This role involves ensuring microbiological integrity of products and processes, providing technical leadership in microbiology-related risk assessments, method development, and compliance with regulatory requirements.
Responsibilities
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
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
Partner with sterilization engineers to establish and maintain validated sterilization processes
Support packaging integrity and EO residual testing strategies
Author and review microbiology-related sections of regulatory submissions (510(k), CE marking, etc.)
Ensure adherence to GMP, ISO 13485, and FDA QSR requirements
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
Identify opportunities to optimize microbiological testing efficiency and reliability
Mentor junior associates and contribute to knowledge-sharing initiatives
Qualification
Required
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
Benefits
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
Company
CHEManager International
Wiley’s leading media brand providing first-hand information on the global chemical, life science and process industries
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase