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Job Description
Microbiology Specialist Durham, NC Job Details Full-time $43.07 - $80.00 an hour 1 day ago Benefits Disability insurance Health insurance Paid time off 401(k) matching Qualifications Biology Stability testing Biochemistry Microbiology GLP Technical documentation 5 years Pharmaceutical regulatory compliance GMP Technical report writing Microbiology Bachelor's degree in biology Bachelor's degree Continuous improvement Scientific protocols Laboratory quality control Microbiological analysis Manufacturing Sterile laboratory techniques Senior level Cross-functional collaboration Bachelor's degree in microbiology Bachelor's degree in biochemistry Manufacturing company experience Cross-functional communication FDA regulations Assays Full Job Description Summary If you're driven by protecting patients through rigorous contamination control and scientific excellence, this is your opportunity to make a meaningful impact every day. As a Microbiology Specialist, you'll play a critical role in ensuring the quality, safety, and integrity of our products by leading microbiological testing, method verification, and environmental monitoring activities within a highly regulated manufacturing environment. You'll partner closely with cross-functional teams to support investigations, qualifications, and continuous improvement initiatives, while applying your expertise to data review, trending, and technical documentation. This role offers the chance to work hands-on with advanced microbiology processes, influence site readiness, and serve as a trusted subject matter expert—contributing directly to Novartis' mission to deliver high-quality medicines to patients worldwide. #
LI-Onsite Location:
Durham, NC, USA Shift:
1st; 2 positions available This role is based in Durham, NC, USA. Novartis is unable to offer relocation support: please only apply if this location is accessible for you.
About the Role Key responsibilities:
Writing of all protocols and reports for verifications of Microbiology and EM methods into Tricenter for
LIVI ADP
(bioburden, endotoxin, sterility, EM, Utilities etc). Perform microbiological qualification, release, stability, and investigational testing to support compliant manufacturing operations. Author and maintain protocols and reports for microbiology and environmental monitoring method verification and validation activities. Execute method transfers and verifications for microbiology and environmental monitoring assays across laboratory systems. Maintain qualification, control, and trending of critical reagents, standards, and microbiology controls. Review and approve routine and transfer data, supporting deviations, change controls, and quality investigations. Coordinate environmental monitoring performance qualification, site assessments, media fills, and utilities qualification activities. Perform microbiological testing of materials, utilities, and environmental and personnel monitoring samples. Analyze trends and performance indicators while supporting sample planning and execution across laboratory activities.
Essential Requirements:
Bachelor's degree in biochemistry, biology, microbiology, or a related scientific discipline. Minimum five years of experience working in a Good Manufacturing Practice environment. Proven experience performing microbiological testing, including utilities testing and environmental and personnel monitoring. Demonstrated ability to write protocols, verification documentation, and technical reports using Good Documentation Practice. Experience reviewing and approving laboratory data, supporting deviations, investigations, and change controls. Strong knowledge of Good Laboratory Practice and Good Documentation Practice principles. Understanding of United States Food and Drug Administration and European Medicines Agency regulatory expectations. Ability to gown for entry into aseptic areas and lift approximately 25 pounds. Novartis Compensation and Benefit Summary The salary for this position is expected to range between $43.07/hour and $80.00/hour. The final salary offered is determined based on factors such as relevant skills, experience, and market considerations, and will be reviewed periodically upon joining Novartis. Novartis may adjust the published salary range based on company and market factors. Compensation includes eligibility for a performance-based incentive. U.S.-based eligible employees will receive a comprehensive benefits package, including health, life, and disability insurance, a 401(k) with company contribution and match, and generous paid time off.
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
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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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & 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 to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Division Operations Business Unit Quality Location USA State North Carolina Site Durham Company / Legal Entity U473 (FCRS = US473) Novartis Gene Therapies Functional Area Quality Job Type Full time Employment Type Regular Shift Work No VIDEO
