Position Purpose:
The Technical Expert – Global MS, based in the Capability Hub, provides specialized technical support and product stewardship for assigned Sandoz manufacturing sites and external suppliers (CMOs). The role ensures robust, compliant, and well‑controlled manufacturing processes through hands‑on support in process validation, technical investigations, product transfers, and preparation of technical documentation. The position serves as a key technical interface across internal sites, external partners, Development (SDC), and ESO to enable reliable product supply and technical compliance.
Your Key Responsibilities:Your responsibilities include, but not limited to:
- Technical Transfer Lead -Review and update Quality Risk Assessment (QRA) prior to transfer and prior to validation, adapt control strategy if needed.
- Review first APQR after transfer to ensure adequate product performance -Ensure that all relevant technical information and documentation for validation is available.
- Define pre-validation / validation strategy incl. process, cleaning, packaging and supportive studies (e.g., hold times).
- Coordinate technical, regulatory and validation batches at site.
- Support Validation Lead / Validation Expert in creation of validation protocol and report.
- Product Steward And -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.
- Create and maintain a product specific Quality Risk Analysis (QRAs).
- Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
- Review APQR and decide on state of control.
- Technical Steward -Act as the SPOC for the interface with global MSAndT network and with technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment.
- Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE).
- Provide technical expertise for validation activities around technologies within area of responsibility.
- Harmonize and optimize technical processes across the site.
- Validation Lead -Support Product Steward in maintaining the process control strategy.
- Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).
- Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities.
- Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV), ongoing cleaning verification.
- Senior Scientist MSAndT -Complex projects with deep understanding of development process requirements -Difficult to solve topics (eg. new by-product investigation, complex deviations) -Cross product alignment in support approach (larger sites) -Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable).
What you’ll bring to the role:Essential Requirements:
- BSc. in Pharmacy, B. Pharma, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
- Minimum 8+ year experience in Process support, Documentation and Lab and Shopfloor experience of pharmaceutical manufacturing.
- Proven process understanding (Pharma, GMP, Regulatory aspects).
- Sound experience of data handling and applied statistics is a must.
Why Sandoz?
Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!
Join us, help us make healthcare fairer and faster.
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.
