Sterility Assurance Lead
Sterility Assurance Lead
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Job Description
Job Description Summary
This position will be located at Durham NC and will not have the ability to be located remotely.The Sterility Assurance Lead serves as the key functional expert for aseptic processing at the Durham NC facility. The incumbent will be responsible for providing technical leadership direction and management of sterility assurance quality operations to support aseptic manufactured products. This includes 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 sterility assurance.
#LI-Onsite
Key Responsibilities:
Provides leadership and oversight to Quality Operations aseptic oversight.
Lead supervision of aseptic processing monitoring (Aseptic Process Simulation)
Review approve and provide input to the Contamination Control Strategy for the site
Provide quality assurance oversight/support of microbiological aspects related to manufacturing as environmental monitoring gas/water monitoring and Bioburden monitoring.
Lead and/or contribute to global aseptic projects including stakeholder management.
Review approve and provide input and support of conceptual procedures in aseptic behavior and aseptic processes and ensuring their implementation as well as ensuring compliance with current regulatory requirements
Supports development and implementation of contamination control strategies
Provide oversight for product/process deviations local and global escalations change controls and audits/inspections ensuring escalation and remediation of critical issues related to aseptic processes.
Support root cause investigation and CAPA initiatives for microbiological contamination events/deviations
Support root cause investigation and CAPA initiatives for microbiological contamination events/deviations
Provide QA oversight and support microbiological/aseptic best practices training program development and execution to foster culture of compliance and excellence
Collaborate closely with site operations and quality to integrate comprehensive microbiological control measures site-wide
Job Description
Requirements:
- B.S. degree in scientific field preferably in Microbiology with 6 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
- 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
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $132300 and $245700/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.
Company will not sponsor visas for this position.
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
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 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 to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$132300.00 - $245700.00Skills Desired
Audit Management Communication Skills Continued Learning Dealing With Ambiguity Decision Making Skills Employee Performance Evaluations Gmp Procedures Inspection Readiness Organizational Skills People Management People Management and Leadership Product Release Qa (Quality Assurance) Self-Awareness Technological ExpertiseEmployment Type
Full-Time
