Integra LifeSciences · 4 days ago
Sr. Manager, Microbiology Reliability - Tissue Technology
Princeton, NJ
Full-time
Hybrid
Mid, Senior Level
$125K/yr - $172K/yr
6+ years expIntegra LifeSciences is committed to innovating new treatment pathways to advance patient outcomes in healthcare. The Sr. Manager, Microbiology Reliability - Tissue Technology will manage personnel interpreting microbiological testing data and ensuring compliance with sterility assurance in medical device manufacturing.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Hiring Manager
Patrick Rogers
Responsibilities
Support the team in generation and execution of microbial method validation protocols and reports including the review, writing, routing and approval of summary documentation
Design experimental plans to address specific laboratory or testing issues, as needed
Manage sample/testing processing with onsite and third-party labs, ensure timely testing and result reporting
Ensure compliance of microbiology procedures, validations, and records with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, ISO 14644, ISO 14698, BS EN 17141, EU GMP Annex 1, ISO 11135, ISO 11764, ANSI/AAMI ST98, ISO 11137, ISO 11737-1/2/3, ISO 11765, ISO 11138, ANSI/AAMI ST 72and USP
Support team members by interpreting microbiological data in order to identify trends and issues that require investigation
Contribute to risk management activities including PFMEA generation for various manufacturing locations
Scheduling coordination, material allocation and alignment of personnel in order to successfully complete project assignments
Support the creation of site procedures for microbiological testing and sampling in alignment with validations and in compliance with application regulations
Ensure the team is maintaining sustained compliance of manufactured products through the completion of microbial trend analysis, investigations, change assessment, and sterilization process requalifications
Mentors non-senior level microbiology staff
Support and serve as Microbiology representative on cross-functional teams for transfer, NPI, and other projects as necessary, including supervision of contract resources
Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements
Support and address comments and suggestions associated with sterilization and microbiological test method validations and monitoring procedures
Change control, non-conformance and CAPA support
Support management with providing direction to the team, coordinating workflow, and providing guidance in the resolution of problems or areas of concern
Participate in FDA inspections, ISO certifications, surveillance audits and customer audits
Qualification
Required
Experience managing as well as interpreting and applying standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of interpreting data, tactical planning on a daily basis, implementing procedures, and remediation projects
Senior-level professional/team player with advanced knowledge and experience who thrives in a team environment but also has the capability to work alone to research and investigate
Understanding of clean room practice/cGMP and laboratory/GLP environments
Understanding the concepts of risk management as it relates to microbial monitoring and sterility assurance in a medical device manufacturing environment
Bachelor's degree or equivalent with 8+ years of experience, Master's degree with 6+ years of experience, Doctoral degree with 4+ years of experience
Bachelor's, or preferably Master of Science degree, in Microbiology or similar discipline
Experience managing multiple teams and results oriented with a strong focus on quality principles
Demonstrates excellent team management, organizational and communication skills
Excellent technical writing skills with an understanding of good documentation practice
Experience conducting microbial test method validations and managing projects independently
Experience creating and changing procedures used in operations for microbiological monitoring of the environment and products
Working knowledge of applicable microbiology standards including, but not limited to, ISO 14644, ISO 14698, BS EN 17141, EU GMP Annex 1, ISO 11135, ISO 11764, ANSI/AAMI ST98, ISO 11137, ISO 11737-1/2/3, ISO 11765, ISO 11138, ANSI/AAMI ST 72 and USP
Ability to manage teams, track milestones and manage projects
Working knowledge of applicable regulations and their interpretation within industry
Ability to travel up to 30%
Ability to utilize a computer, personal electronic devices, as well as other general office equipment
Strong computer skills
Preferred
Experience with personnel management, complex project leadership and development of junior-level technical employees
Experience with Controlled Environment Monitoring, Water system monitoring, compressed air monitoring, Bacterial endotoxin test method validation and monitoring, Bioburden test method validation and monitoring, and radiation sterilization and dose audit management
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
1001-5000 employees
H1B Sponsorship
Integra LifeSciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO
Leadership Team
Mojdeh Poul
Chief Executive Officer
Lea Knight
EVP and Chief Financial Officer
Recent News
Integra LifeSciences Holdings Corporation
2025-12-02
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