Product Steward

391693BR

**Product Steward**:
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 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**

Responsible for scale-up and transfer for cold 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.
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.
**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 SPOC.
- Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
- Ensure inspection readiness for all process related aspects of assigned products.
- Track and evaluate product performance, trending, detect issues, implementation of CAPAs.
- Support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams.
- Act as SPOC 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.
- Initiate local change control in system on site and ensure approval and closure.
- Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities.
- Ensure timely availability of technical documentation according to Novartis guidelines.

**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 3 years of experience in executing equipment qualifications, process validation, having led and managed validation projects, including sterile manufacturing.
- Ideally 3 years of experience in manufacturing, MS&T or quality department.
- Expert in reviewing and writing technical reports.
- Fluent in English and Italian.

Work location: Saluggia (VC).

**Division**

Oncology

**Business Unit**

ADVANCED ACCELERATOR APPLICATIONS

**Work Location**

Saluggia

**Company/Legal Entity**

AAA Italy Srl.

**Functional Area**

Technical Operations

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes