341233BR
Jun 20, 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 Sr Process Scientist owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability through data trending and statistical analysis of critical variables, and ensures process(es) are robust, in continued state of validation and continuously improving. Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s). Provides second line technical/scientific process support. Manages and collaborates with external consultants to achieve document generation and execution according regulatory and project requirements.

Your responsibilities include, but are not limited to:

• Maintain the oversight and knowledge for entire manufacturing process performed on site throughout the entire commercial lifecycle, act as SPOC.
• Ensure an appropriate process control strategy is in place based on CQAs and where necessary on CPPs and/or CMAs. Support improving the control strategy where applicable.
• Create Process Validation protocols and generate reports (as needed) and responsible for ensuring the continued state of validation (process, cleaning, etc.).
• Monitor all critical variables, key variables, In Process Controls (IPC) and release parameters as appropriate using statistical analysis and conducting regular product specific data trending.
• Lead/support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams.
• Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed.
• Provide SME expertise to perform process characterization to increase robustness and sustainability.

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

What you'll bring to the role:

Bachelors degree in Pharmacy, Pharmaceutical Technology, Chemistry, Chemical engineering, or equivalent scientific degree. (MSc., PhD) a plus; Degree in Radiochemistry or Radioactive Products manufacturing is a plus.

5 years experience in process support, e.g. Process Expert role on the shop floor of pharmaceutical manufacturing and/or QA/QC
• Proven process understanding (Pharma GMPs, Aseptic Processing, Validation and Regulatory aspects).
• Strong understanding of risk assessment and risk management fundamentals/tools
• Excellent problem solving and decision-making skills
• Sound experience of data handling and applied statistics and strong in defining and implementing productivity improvement measures

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
Indianapolis, IN
Technical Operations
Full Time
Regular
No
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341233BR

Sr Process Scientist

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