332426BR
May 27, 2022
Italy

Job Description

The Technical Transfer Expert in Lyophilization will be responsible for scale-up and transfer for cold products by developing and carrying out a validation strategy according to cGxP. It will also complete and handle new product introductions for clinical supplies and commercial supplies considering process, primary packaging, cleaning validation activities and change management activities to meet cGMP requirements on time and quality. It will establish and optimize lyophilization formulation and cycle to ensure fit for purpose processes and supports investigations during lyophilization issues

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to commercial manufacturing to divestment or pruning.
• Assess impact of technical changes, assess their technical feasibility and resolve scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed
• Act as Point of Contact on site for technical transfer. Participate in transfers and launches, collaborate closely with technical development for new products and align on the product validation approach. Provide technical expertise for pre-validation / validation strategy
• Support the industrialization of the lyophilization processes, define and prepare processes and procedures in collaboration with the Technical Research and Development. Perform root cause investigation and propose lyophilization cycle improvements.
• Establish site project plan, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles and propose solutions. Assess and plan site resource needs and get management approval for the overall project costs (e.g. FTEs, batch costs, investments and external costs), strategies, and timelines.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

• Languages: Proficient level of English and Italian
• Education: BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology. Desirable PhD in the above or equivalent.
• At least 2 years of experience in a similar role

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!

Imagine what you could do at Novartis!

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
Italy
Saluggia
Technical Operations
Full Time
Regular
No
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332426BR

Technical Transfer Expert in Lyophilization - AAA

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