Product Expert

6 giorni fa

Montà, Italia Novartis A tempo pieno

387159BR
**Product Expert**:
Italy
**AAA Statement**
**Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients' lives by leading innovation in nuclear medicine.**
**Advanced Accelerator Applications, a Novartis company, offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).**
**About the role**
The Product Expert is responsible for scale-up and transfer for RLT (radioligandtherapy) products by developing and executing a validation strategy according to cGxP, executing and managing new product introductions for clinical supplies and commercial supplies considering process, primary packaging, and cleaning validation activities and change management activities to meet cGMP requirements on time and quality.
This person 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, ensuring process(es) are robust, in continued state of validation and continuously improving.
Moreover, he/she 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.
**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 date, act as Site Point of Contact.
- Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
- 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/
- Act as Point of Contact on site for technical transfer. Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Provide technical expertise for pre-validation / validation strategy.
- Provide input into overall project strategy and plans including timelines.
- Form and lead site project team - set priorities for project and project team meetings, coordinate project team activities, ensure that Novartis guidelines and HSE and GMP guidelines are met.
- Ensure timely availability of technical documentation according to Novartis guidelines. Write Manufacturing Process Transfer Documents (protocol, report).
- Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV).
- Ensure that all manufacturing and cleaning processes are validated; overview on state of validation at site is maintained.
**Commitment to Diversity & Inclusion**:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Role Requirements**
**What you'll bring to the role**:
- Scientific or Engineering Degree.
- At least 2-3 years of experience in executing equipment qualifications, process validation, having led and managed validation projects, including sterile manufacturing.
- Ideally 2-year experience in manufacturing, MS&T or quality department.
- Expert in reviewing and writing technical reports.
- Fluent in English. Proficient in Italian.
Work location: Colleretto Giacosa (TO).
**Why Advanced Accelerator Applications?**
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, 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 ambiti

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