342880BR
Apr 27, 2022
USA

Job Description

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!

The Process Expert provides front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards.

Your responsibilities include, but are not limited to:

Stewardship
• Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
• Responsible for maintaining the master manufacturing documents of assigned products (e.g., Master Batch Record, Bill of Material (BOM) & Recipe, Quality Risk Assessment).
• Ensure that all critical parameters are within written Instruction (e.g. Master Batch Record, Quality Risk Assessment, Validation Protocol).
• Support steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy.
• Ensure that all process changes in assigned products are managed through appropriate change con-trol procedure.
• Ensure creation of production SOPs and Master Batch Records.
• Act as Subject Matter Expert (SME) for the product and process knowledge, be highly knowledgeable of product and process trends by providing input to APQR for analysis and for driving process technology innovations.
• Collect data for ongoing process verification (OPV), support product steward in tracking and evaluation of product performance and implementation of CAPAs.
• Perform first line evaluation of product and process related issues (deviations, complaints, OOS).
• Support product steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy.
• Maintain processes at inspection readiness level.
• Support process optimization establishment and new technology introduction for continued productivity improvement, as appropriate.
Validation
• Review validation protocols and reports for technical correctness.
• Support the execution of process validations, and short-term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution.
Manufacturing Excellence
• Execute process improvements and scale-up.
• Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables.
Training:
• Own the Training Curriculum for own Job profile.
• Support technology trainings and education programs for production operators.

POSITION SCHEDULE: Sunday-Thursday 3PM-11PM

https://www.youtube.com/watch?v=4A1joFLTfo0

Diversity & Inclusion / EEO

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:

Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
3 years experience in a process support shop floor role in GMP manufacturing and/or QA/QC.
• Proven process understanding (Pharma, GMP, Regulatory aspects).
• Strong affinity with and awareness of quality issues
• Excellent technical writing skills

Why Advanced Accelerator Applications (AAA)?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine?
We believe new groundbreaking 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!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. 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:
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.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
USA
Millburn, NJ
Technical Operations
Full Time
Regular
No
careers default image
342880BR

GMP Process Expert

Apply to Job Access Job Account