343247BR
Jun 21, 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 Site Validation Lead provides the site with Subject Matter Expert (SME) knowledge and skills, of specific pharmaceutical processes or process technologies and project management (e.g. Aseptic Processing changes and new projects, Isolator Technology, Trasis synthesis Units, Vial Dispensing Units, etc.).

Your responsibilities include, but are not limited to:
Validation
• Responsible for the generation upkeep and execution of the Site Validation Masterplan each year
• Responsible for coordinating tasks linked to execution of activities listed on site validation masterplan
• Generates or Approves validation protocols and reports under their area of responsibility (as needed).
• Provides technical expertise for validation activities around technologies within area of responsibility.
• Takes the lead on determining validation strategy for new processes and technologies
Launch & Transfer
• SME for specific Technology Platform or pharmaceutical processes following process product/process transfer or handover from launch to commercial production.
Stewardship - for technologies assigned:
• Acts as the SPOC for the interface with global MS&T network and with the technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment. Collaborate with technical development, other sites, and global MS&T network to facilitate transfer of technical knowledge.
• Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE).
• Participate in the definition and selection of pharmaceutical equipment, through providing input to User Requirements.
Training:
• Provide technical training and education for Process Experts and production operators.


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 Chemical Engineering, Pharmaceutical Technology, or equivalent scientific degree.
Masters or PhD a plus. Degree in Radiochemistry is a plus
• Minimum 5 years’ experience in GMP manufacturing relevant to the
area of expertise.
• Proven process understanding (Pharma GMP, Aseptic Processing, Validation and Regulatory aspects).
• Sound experience of data handling and applied statistics is a must.
• Strong understanding of risk assessment and risk management fundamentals/tools
• Team building and process harmonization skills
• Excellent verbal and written communication skills,
• Excellent problem solving and decision-making skills
• 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
Millburn, NJ
Technical Operations
Full Time
Regular
No
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343247BR

Site Validation Lead

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