Quality Control Microbiologist

Band

Level 4

 

Job Description Summary

The Plant Microbiologist serves as the key functional expert for microbial control and product quality and safety at the Durham, NC facility. The incumbent will be responsible for providing technical leadership, direction, and management of microbial controls to support aseptic manufacturing of the site. This includes supporting the site Sterility assurance personnel with the development and optimization of current processes and programs to ensure compliance with regulatory requirements, organizational development, and making appropriate decisions and recommendations to address trends, issues, or significant observations related to microbial events. In addition, this position would manage a team within the Quality Control department. This position would coordinate and support compliance activities within the Quality Control department as well as support development, validation, and external and project activities as needed. This role is 100% on site.

 

Job Description

Provides technical leadership and expertise in microbial control, ensuring compliance with cGMP and regulatory requirements, supporting site readiness for inspections, leading contamination investigations, driving new technology implementation, and maintaining industry knowledge, while collaborating across functions and acting as a role model and talent sponsor.

• Environmental Monitoring & Trend Analysis: Regularly monitor environmental data in the manufacturing environment to detect trends and manage microbial contamination. This includes rigorous oversight of air, surface, and personnel monitoring. This position would also ensure the trending reports are published on time and in full.
• Product Testing & Quality Assurance: Oversee microbiological testing across product stages, including sterility, endotoxin, and microbial limits testing, to ensure compliance with stringent microbiological quality standards.
• Author and review quality documents (ie protocols, reports, SOPs, Test Methods, technical documents and risk assessments)
• Contribute, support and lead writing of OOS/OOE/OOT and deviation investigations. Drive CAPA outcomes)
• Plan/schedule, supervise, and execute/review of in-process, development, validation, and release testing on samples while working with cross functional stakeholders to meet company quality standards and timelines.
• Contamination Control Strategy Development: Support the development and implementation of contamination control strategies, including the selection and application of disinfectants and sanitizers, while promoting optimal gowning and hygiene practices.
• Quality Oversight & Escalation: Provide quality oversight for product/process deviations, change controls, and audits, ensuring escalation and remediation of critical issues, and participate in both Site and Global Quality sterility assurance processes.
• Training & Development: Conduct training sessions for staff on microbiological best practices and contamination control protocols to foster a culture of compliance and excellence.
• Cross-Functional Collaboration: Collaborate closely with site operations, quality leads, Novartis representatives, and quality leaders to integrate comprehensive microbial control measures site-wide.
• Will support Novartis projects for assessment of capacity planning and laboratory or site requirements as a technical SME.
• This project based role may engage in other site planning activities to provide leadership and technical expertise for sites beyond the GTX location.
• May manage multiple contract or FTE reports that focus on project work for different projects that incorporate EMPQs, Media simulations, Utility qualifications, onboarding new microbiology laboratory spaces, cleanroom classifications, and implementing new filling technologies.
• This role may also double as an SME for different projects as a microbiologist within the Novartis network for capacity planning and operational excellence.
• Technical Leadership in Microbial Control: Provide technical leadership in microbial control, ensuring full compliance with cGMP and regulatory requirements and acting as a point of contact for technical expertise.
• Regulatory Support: Offer expert guidance and technical support during preparation for regulatory and internal inspections, ensuring adherence to standards.
• Contamination Investigation & CAPA: Lead and support root cause analyses and CAPA (Corrective and Preventive Actions) initiatives for microbial contamination events.
• Microbial Controls Justification for CGT Products: Support the team in defining and justifying microbial controls and limits for Cell and Gene Therapy (CGT) products.
• Risk