Product Steward (Product Life Cycle Owner)

About the position

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for an experienced pharmaceutical professional to help us reach our ambitious goals. As the Product Steward, you will be part of our Manufacturing Science and Technology (MSAT) team and own the process knowledge of products throughout the commercial lifecycle, maintain oversight of process capability, ensure processes are robust, in continued state of validation, and continuously improving. You will facilitate the seamless flow of knowledge and information across functions, and with other Sites, and provide second line technical/scientific process support.

Responsibilities

• Maintain the process control strategy. Monitor all critical variables and key variables using statistical analysis and conducting regular product specific data trending.
• Review Annual Product Quality Review (APQR) to ensure products and processes are in a state of control.
• Create and maintain product Quality Risk Analysis (QRA).
• Assist in initiating the product monitoring of all critical In Process Controls (IPC) and release parameters in each laboratory.
• Maintain oversight and knowledge of the entire manufacturing process performed on site and throughout the entire commercial lifecycle, acting as the Single Point of Contact (SPOC).
• Track and evaluate product performance, detect issues, implement Corrective and Preventive Actions (CAPAs), and lead or support root cause investigations of process failures.
• Present product performance and status of product improvement projects in site Manufacturing Robustness Review Board (MRRB).
• Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches.
• Ensure creation of Master Batch Record and own change control. Support registration activities as needed.
• Ensure the continued state of validation (process, cleaning, ongoing verification etc.).
• Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV).
• Ensure that the ongoing verification report (OPV) is established on time in alignment with the APQR.
• Support site validation planning by reviewing and approving validation protocol and report related to technical changes for processes, cleaning, packaging processes and ongoing verification for processes and cleaning (as applicable).
• Work in close collaboration with development organization (or sending site) for technical transfers and new product launches.
• Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation.
• Provide the necessary data for technical activities involved in transferring out a product.
• Design and manage optimization projects, provide SME expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability.
• Collaborate with Operational Excellence (OPEX) for product and process improvements.

Requirements

• BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology.
• 5 years of experience in process support, manufacturing, manufacturing science and technology, technical development or quality.
• Proven process understanding - thorough understanding of manufacturing processes and related process equipment.
• Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.
• Expert in reviewing and writing technical reports.
• Sound experience of data handling and applied statistics.

Benefits

• 401(k) eligibility
• various paid time off benefits, such as vacation, sick time, and parental leave
• sign-on bonus
• restricted stock units
• discretionary awards