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 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 Assessment & Validation Support: Support the preparation and delivery of Validation Plans Site Quality Risk Assessments and Quality Assessments relevant to sterility assurance.
• Process & Equipment Validation: Participate in validation activities for aseptic processes cleaning procedures and equipment ensuring effective microbial contamination control.
• Industry Knowledge & Regulatory Awareness: Stay current with industry advancements emerging technologies and evolving regulations to ensure proactive alignment with external standards for Cell and Gene Therapies.
• Regulatory Representation & Audit Support: Provide technical expertise for marketed and clinical products representing Novartis in regulatory discussions and supporting audit preparations and submissions.
• Technology Implementation for Microbial Monitoring: Drive the implementation of innovative technologies for enhanced microbial monitoring and control.
• Talent Development & Mentorship: Sponsor potential talent contributing to the development of a robust talent pipeline within the organization.
• Trains and educates employees and promotes adherence to quality control procedures policies standards and best practices to foster a culture of quality awareness and accountability.
• Plays a key role in the development and growth of direct reports providing guidance coaching and support to enhance their performance and career progression within the organization.
• Values-Driven Leadership: Model Novartis Values Behaviors and leadership standards inspiring high performance and alignment across the team.

Minimum Requirements:

• B.S. degree in scientific field preferably in Microbiology with 5 years experience in biopharmaceutical based GMP manufacturing operations including direct experience in managing sterility assurance programs for biotechnology manufacturing facilities

  or Masters Degree with 6 years experience in biopharmaceutical based GMP manufacturing operations including direct experience in managing sterility assurance programs for biotechnology manufacturing facilities

• Management experience of at least 2 years
• Deep understanding of microbiology
• Understanding of aseptic processes.
• Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.
• Excellent verbal written communication skills and the ability to interface with multiple areas within the organization is essential.
• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward for microbial contamination events.
• Demonstrated ability to perform long-term project planning team building budgeting and operational excellence.
• The global nature of the job requires the position to have excellent knowledge of the various regulatory and GMP requirements as well as outstanding communication skills.
• Strong biotech background in cGMP Manufacturing of Drugs (cellular or gene therapies proteins)
• Strong quality background in understanding of quality systems and regulatory requirements
• Ability to work under pressure ability to assert oneself fast decision making high flexibility

Languages:

• English

The pay range for this position at commencement of employment is expected to be between $114100 and $211900/year; however while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a sign-on bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

$114100.00 - $211900.00

Skills Desired

Continued Learning Dealing With Ambiguity Decision Making Skills Gxp Industry Standards Laboratory Equipment Laboratory Excellence Managing Resources Organizational Savvy Quality Control (Qc) Testing Quality Control Sampling Self-Awareness Smart Risk Taking Technological Expertise Total Quality Management