Manager, Microbiology

Coloplast has an exciting opportunity for a Microbiology Manager to join our team.

In this role, you will establish, implement, and improve best practices for meeting FDA, ISO and Coloplast requirements with respect to product sterility assurance and microbiology. You will also lead the microbiology laboratory and team.

Major Areas of Accountability

• Team and Laboratory
  • Manage and direct the Microbiology Team, Laboratory, and functional activities.
• Cross Functional Collaboration
  • Act as liaison between Microbiology and the Manufacturing, Engineering, R&D, Regulatory, and Corporate departments with respect to microbiological and sterilization activity.
  • Collaborate with contract sterilizers to introduce new sterilization cycles or adopt existing cycles when applicable - including development, modification and validation of the cycles.
• Sterilization (Ethylene Oxide and Gamma)
  • Ensure the continued suitability and validation of contract sterilizer facilities, sterilization cycles, and manufactured load configurations.
  • Resolve emerging sterilization, controlled environment, or microbiological issues arising from NCRs, CAPAs, and audits - including the disposition of product.
  • Support product and packaging design decisions to ensure sterility - including introduction of new products and changes to commercialized products.
• Microbiology
  • Maintain clean room certification - managing requirements, activities, changes, and reporting.
  • Incorporate new or modified industry standards and best practices for product sterility, endotoxin, bioburden, and environmental monitoring testing.
• Biocompatibility
  • Develop organizational capacity to support biocompatibility related deliverables.

Job-Specific Duties

• Participate as an R&D product development team member by attending meetings, providing guidance on issues of sterilization and microbiology, and completing assigned tasks and deliverables on time.
• Plan and execute product sterilization cycle validations and re-validations, including preparation of the protocols and reports, in accordance with Coloplast and recognized industry standards.
• Provide rationale for the adoption of any existing sterilization cycle for a new product.
• Drive, review and approve sterilization validation protocols and reports issued by contract sterilizers.
• Perform quality/surveillance audits of contract sterilizers to ensure Coloplast, ISO and GMP compliance.
• Review and approve test reports for clean room certifications and product sterility, endotoxin / pyrogen, bioburden, and environmental monitoring tests.
• Establish and/or document appropriate alert, action and specification levels for product bioburden and clean room particulate and microbial counts.
• Provide guidance to R&D, Engineering, and Manufacturing regarding cleaning validations.
• Develop, revise, and validated test methods and procedures.
• Support regulatory submissions and questions/responses; facilitate and support external audits.
• As needed, provide hands-on testing support in the Microbiology Laboratory, including setup, execution, and performance of microbiological testing (sterility, bioburden, LAL, assays, etc.).
• Provide and/or review a compliance status overview for quarterly quality management review.
• Perform tasks necessary for execution and reporting of routine dosimetric audits for gamma-sterilized products.
• Bachelor's degree (B.S.) in microbiology, biochemistry, biology or related field from an accredited four-year college or university.
• Minimum eight years related experience and/or training, or equivalent combination of education and experience.

Required Knowledge, Skills and Abilities

• Ability to effectively develop, champion, and communicate objectives and actions.
• Ability to guide professional development of laboratory personnel.
• Ability to work as a project team member.
• Ability to lead and document effective root cause analysis and failure investigations.
• Ability to complete project deliverables on time and in compliance with regulatory requirements.
• Knowledge of FDA and ISO 13485 quality systems regulations.
• Experience in EtO gas, gamma radiation, and other sterilization validation methods and requirements per ISO 11135 and ISO 11137.
• Experience conducting bioburden, LAL endotoxin / pyrogen testing and device sterility testing.
• Experience with internal and supplier auditing.
• Experience with biocompatibility requirements, regulations, and testing.
• Effective organizational, management, and communication skills
• Personifies and fosters the Coloplast Mission, Vision and Values

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark