394675BR
Mar 20, 2024
USA
About the Role
The Manager, Quality Control Microbiology Technical Support, is responsible for providing technical support to QC and Manufacturing and managing a team to conduct investigations.
Supports QC Microbiology in managing the transfer and technical oversight of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability).
Establishes user requirements for purchase, qualification of QC equipment and work with internal and external resources to maintain equipment in an optimal state.
Develops, revises and reviews SOPs, qualification/validation protocols and reports.
Reviews and manages team to conduct investigations regarding out of specifications (OOS) results and EM excursions.
Monitors the GMP systems currently in place to ensure compliance with documented policies.
Manages Aseptic Gowning, Aseptic Techniques and Microbiology Training
Gathers metric information for use in continuous improvement of areas of responsibility.
Project management for QC related projects.
Supports QC Microbiology in managing the transfer and technical oversight of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability).
Establishes user requirements for purchase, qualification of QC equipment and work with internal and external resources to maintain equipment in an optimal state.
Develops, revises and reviews SOPs, qualification/validation protocols and reports.
Reviews and manages team to conduct investigations regarding out of specifications (OOS) results and EM excursions.
Monitors the GMP systems currently in place to ensure compliance with documented policies.
Manages Aseptic Gowning, Aseptic Techniques and Microbiology Training
Gathers metric information for use in continuous improvement of areas of responsibility.
Project management for QC related projects.
Diversity & Inclusion / EEO
We are Equal Opportunity Employers and take pride in maintaining a diverse environment. 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 are committed to building diverse teams, representative of the patients and communities we serve, and 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: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
- Novartis: e-mail [email protected] or call +1 (877)395-2339
- Sandoz: e-mail [email protected] or call: +1-609-422-4098
Role Requirements
Bachelor's degree or advanced degree in Microbiology or related discipline with 8 years’ experience working in a GMP QC Microbiology and Environmental Monitoring laboratories, preferably in an aseptic processing facility.
Ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
Strong knowledge of Environmental Monitoring equipment, requirements and tests (viable and non-viable), Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals.
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/1271, ISO 14644-1, USP, EP).
Extensive experience in conducting laboratory and environmental excursion investigations.
Previous training experience.
Ability to communicate and work independently with scientific/technical personnel and comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
Ability to think critically and demonstrate troubleshooting and problem-solving skills.
The pay range for this position at commencement of employment is expected to be between $112,800 and $169,200 annual; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
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 [email protected] 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.
Ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
Strong knowledge of Environmental Monitoring equipment, requirements and tests (viable and non-viable), Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals.
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/1271, ISO 14644-1, USP, EP).
Extensive experience in conducting laboratory and environmental excursion investigations.
Previous training experience.
Ability to communicate and work independently with scientific/technical personnel and comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
Ability to think critically and demonstrate troubleshooting and problem-solving skills.
The pay range for this position at commencement of employment is expected to be between $112,800 and $169,200 annual; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
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 [email protected] 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.
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? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Operations
QUALITY
USA
Durham, NC
Novartis Gene Therapies
Quality
Full Time
Regular
No
