394674BR
Mar 22, 2024
USA
About the Role
The Specialist, Disposition is responsible for overall quality and disposition of incoming and make materials. This includes raw materials, consumables, media, buffers, intermediates, drug substance and drug product, as required.
Collaborates with suppliers to ensure incoming documentation is in adherence to Novartis standards and specifications.
· Ensures overall quality and disposition of incoming and make materials (including raw materials, consumables, media, buffers, intermediates, drug substance, drug product and final kit to patient materials).
· Collaborates with manufacturing and manufacturing quality teams to ensure adherence to batch records, clinical protocols, and regulatory requirements for manufactured gene therapies.
· Ensures all area documentation remains in compliance and provides QA support for Quality Systems including deviations, CAPAs and Change Controls.
· Provides quality oversight to warehousing functions including performing walkthroughs, alarm reviews, inventory management, and quality inspection of returns.
· Issues and archives batch records and forms for manufacturing make materials.
· Contribute to the key site metrics for the Quality Management Review meeting (QMR) to ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics, reporting to management all necessary information regarding product release.
· Supports projects to address quality gaps or drive continuous improvement related to Operations or Quality Systems.
· Develop standard work to implement risk-based quality oversight program for Operations and ensure routine activities are completed within established timelines.
May process and release dose packs.
Collaborates with suppliers to ensure incoming documentation is in adherence to Novartis standards and specifications.
· Ensures overall quality and disposition of incoming and make materials (including raw materials, consumables, media, buffers, intermediates, drug substance, drug product and final kit to patient materials).
· Collaborates with manufacturing and manufacturing quality teams to ensure adherence to batch records, clinical protocols, and regulatory requirements for manufactured gene therapies.
· Ensures all area documentation remains in compliance and provides QA support for Quality Systems including deviations, CAPAs and Change Controls.
· Provides quality oversight to warehousing functions including performing walkthroughs, alarm reviews, inventory management, and quality inspection of returns.
· Issues and archives batch records and forms for manufacturing make materials.
· Contribute to the key site metrics for the Quality Management Review meeting (QMR) to ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics, reporting to management all necessary information regarding product release.
· Supports projects to address quality gaps or drive continuous improvement related to Operations or Quality Systems.
· Develop standard work to implement risk-based quality oversight program for Operations and ensure routine activities are completed within established timelines.
May process and release dose packs.
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 in engineering, microbiology, chemistry or biochemistry with 3 years equivalent industry experience in Batch Disposition and/or Quality Assurance in a GMP environment OR
· 3 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification, or aseptic fill/finish.
· Experience with clinical manufacturing, viral gene therapies and/or orphan disease indications is a plus.
· Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities.
· Self-starter with an understanding of GMP requirements, acute attention to detail.
· Flexible hours to support patient kits is required.
The pay range for this position at commencement of employment is expected to be between $40.38 and $60.57 hourly; 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.
· 3 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification, or aseptic fill/finish.
· Experience with clinical manufacturing, viral gene therapies and/or orphan disease indications is a plus.
· Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities.
· Self-starter with an understanding of GMP requirements, acute attention to detail.
· Flexible hours to support patient kits is required.
The pay range for this position at commencement of employment is expected to be between $40.38 and $60.57 hourly; 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
