352662BR
Sep 13, 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 QC AS&T Phys-Chem Expert is responsible for supporting the site as an expert in physicochemical analysis of radiopharmaceutical drug products.

Your responsibilities include, but are not limited to:
• Oversight of the performance and troubleshooting of all analytical procedures executed in the QC chemistry labs for the testing of radiopharmaceutical drug products
• Support the site and global AS&T partners in the development and implementation of new analytical procedures
• Perform QC related validations, transfers, improvements, investigations related activities (deviations,
OOS, OOE, OOT, CAPAs, trending), and Change Control systems.
• Manage the training of QC chemists and technicians in current and new analytical procedures
• Support the determination of Laboratory equipment layout, design, qualification and operation to
optimize the usage of the laboratory by increasing flexibility, reducing complexity, optimizing use of
capital and compliance with cGMP.
• Support QC / AS&T Head in management of QC chemistry staff
• Author, review and support procedures, investigations, corrective and preventive actions, change
controls, complaints and training as it relates to quality control chemistry testing
• Evaluate and approve QC records as required
• Prepare and participate in health authorities’ inspections and internal audits of QC. Ensure quality
control area is inspection ready

https://www.youtube.com/watch?v=lhJ9KXNWhEI

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

BS in Analytical Chemistry or relevant scientific field
MS in Analytical Chemistry or relevant scientific field
Fluent in written and spoken English

5+ years of experience in a GMP quality control environment utilizing techniques such as HPLC, pH, bacterial endotoxins, radioactivity dose calibration, iTLC, etc.

• Collaborating across boundaries
• Functional Breadth
• Operations Management and Execution

Competencies:
• Being Resilient
• Breakthrough Analysis
• Interpersonal Savvy
• Operational Excellence
• Organizational Savvy
• Project Excellence

Technical / Functional Skills & Knowledge:
• General HSE Knowledge
• Knowledge of GMP Manufacturing Process Execution
• Transportation
• Quality Control (QC) Testing
• Quality Control Sampling
• Quality Decision Making

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.

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].

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
Indianapolis, IN
Quality
Full Time
Regular
No
careers default image
352662BR

QC AS&T Chemistry Expert

Apply to Job Access Job Account