Associate Expert Drug Supply
Job Posting for Associate Expert Drug Supply at Novartis
1 purpose! Novartis expands its early development and innovative CAR-T cell therapy manufacturing capabilities in its newly launched Center of Excellence, located in the East Hanover, NJ campus. Our therapies are being developed as transformative treatments with life-saving potential for various B cell malignancies and other oncological diseases. We look to be bold with purpose, as we reimagine medicine and lead the way in advancing scientific breakthroughs for patients.
The Associate Expert, Drug Supply is responsible for cell production of patient derived clinical cellular immunotherapy products by functioning as both operator and verifier. Associate Expert, Drug Supply will also be responsible for the formulation and verification of all media. Due to the nature of the starting material (patient cells) this role requires high level of proficiency and ownership of the process and media formulation.
Shift Hours: Monday - Friday / 8am-4pm, however shift schedules could differ based on production schedule. Overtime may be required. Weekend & Holidays may be required.
Your responsibilities will include, but are not limited to:
The Associate Expert, Drug Supply is responsible for cell production of patient derived clinical cellular immunotherapy products by functioning as both operator and verifier. Associate Expert, Drug Supply will also be responsible for the formulation and verification of all media. Due to the nature of the starting material (patient cells) this role requires high level of proficiency and ownership of the process and media formulation.
Shift Hours: Monday - Friday / 8am-4pm, however shift schedules could differ based on production schedule. Overtime may be required. Weekend & Holidays may be required.
Your responsibilities will include, but are not limited to:
- Ownership for the processing of the assigned Patient starting material in the clean room environment to cryopreservation
- Ability to gown aseptically and work in a clean room environment (Grades A-C) areas for extended periods of time
- Executing production batch records utilizing both manual and automated equipment with high level of integrity
- Verification of manufacturing processing include competency with automated cell production equipment and in process environmental monitoring
- Maintains and prepares equipment/environment for use
- Proficient in the use of production related IT systems such as SAP, LIMS and ME
- Documents all steps in the assigned batch record in line with GMP requirements, following ALCOA principles
- Conduct all necessary processing/verification steps for the assigned lot with highest skill level of aseptic technique
- Conduct all necessary processing/verification steps for media with the highest skill level of aseptic technique
- Cryopreservation of Final Product
- Independently own/Assist on Deviation Investigations and Inspections
- Drive and/or assist in implementation and closure of change requests
- Revise/author/review/approve production related documents as needed
- Proactively participates in team meetings, while maintaining a curious mindset
- Ability to learn and adapt to multiple manufacturing processes
- Participation in assigned qualification/validation activities
- Responsible for successful on time completion of required training curriculum comprising of the necessary Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role
- Maintains an “audit ready” module
- Perform other duties as assigned; ie. batch record review, process streamline improvements, safety walk-thru
EEO Statement
The Novartis Group of Companies 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.
Minimum requirements
What you'll bring to the role:
Other Qualifications:
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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 tas.nacomms@novartis.com call 1 (877)395-2339 and let us know the nature of
- Bachelor’s degree in relevant Scientific discipline required with a minimum of 1 year experience in cGMP or academic or lab setting with aseptic or cell culture experience. If no degree, a minimum of 2 years experience in cGMP setting with aseptic or cell culture experience.
- Experience in cell therapy manufacturing preferred
- Aseptic processing in Grade A biosafety cabinets
- Universal precautions for handling human derived materials in BSL-2 containment areas
- Cell expansion, selection, final formulation, cell automated equipment
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
Other Qualifications:
- Ability to work different shift, weekends and overtime will be required. Your shift will be fixed according to business need
- Ability to work with magnetic field equipment
- Ability to lift 50 lbs unassisted
- Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials.
- Ability to adapt and learn new and complex equipment and systems and detailed scientific content
- Ability to collaborate with other groups, teams and departments in addressing process related issues in a highly diverse environment
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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 tas.nacomms@novartis.com call 1 (877)395-2339 and let us know the nature of
Division
Global Drug Development
Business Unit
TECHNICAL R & D GDD
Country
USA
Work Location
East Hanover, NJ
Company/Legal Entity
Novartis Pharmaceuticals
Functional Area
Technical Operations
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
Yes
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Salary.com Estimation for Associate Expert Drug Supply in East Hanover, NJ
$118,160 to $156,582
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Novartis
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Novartis
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Novartis
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