Job Description Summary
The Technical Expert – Global MS&T, 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.
Job Description
Position Purpose:
The Technical Expert – Global MS&T, 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 Support & Product Stewardship: Provide technical expertise to assigned Sandoz manufacturing sites in areas such as process design, equipment understanding, process performance assessment, and troubleshooting. Act as the technical steward for assigned products/sites to ensure processes remain validated, controlled, and capable. Support continued process verification (CPV), data review, and process improvement activities to enhance process robustness. Ensure assigned products remain in a validated and compliant state as per MS&T and regulatory expectations. Contribute to investigations and prepare OPV reports, PPQ documentation, regulatory responses, and scale‑up proposals.
- Validation & Compliance: Support process validation and cleaning validation activities for assigned sites and products. Review and approve validation protocols and reports to ensure scientific robustness and regulatory compliance. Ensure the availability and accuracy of required technical documentation prior to major technical activities, including technical changes at Sandoz sites and CMOs. Provide technical assessments and recommendations for deviations, change controls, CAPAs, and customer complaints.
- Technical Interface & External Supplier Support: Act as a key technical contact between Sandoz sites, CMOs, and Global MS&T for assigned products. Support manufacturing and packaging process evaluations, equipment/technology compatibility assessments, and technology selection as needed. Provide technical input during ESO-led due‑diligence assessments and supplier evaluations. Ensure timely and accurate preparation of documentation needed for risk assessments and supplier qualification activities.
- Product Transfers: Serve as the technical focal point for product transfers involving legacy or new development products. Support transfers from Development to commercial sites, between internal sites, and between Sandoz and external suppliers. Collaborate with Development teams to align on process design expectations during early-stage development. Ensure preparation, review, and readiness of transfer-related documentation (BMR/BPR, process descriptions, control strategies, etc.).
- Cross‑Functional Collaboration & Knowledge Management: Enable timely and effective knowledge transfer related to product and process understanding across internal and external stakeholders. Support development, standardization, and sharing of best practices, technical learnings, and process know‑how across MS&T functions.
- Lifecycle Management: Support identification, assessment, and implementation of alternate suppliers for raw materials or components. Contribute to reformulation or process refinement work where applicable. Perform risk assessments related to product/process improvement and compliance.
- Provide any additional technical support required to ensure business continuity, regulatory adherence, and operational readiness. This may include participation in tactical or strategic initiatives beyond the responsibilities listed above, as needed by the business. Complete all compliance activities in accordance with updated P&O or organizational requirements, adapting to evolving regulations, policies, and business needs.
- Maintain adherence to internal governance processes and support continuous improvement by adopting new practices and standards as required for the effective functioning of the department and the organization.
What you’ll bring to the role:
Essential Requirements:
Bachelors/Masters. in Pharmacy, Pharmaceutical Technology, Chemical Engineering /Chemistry or equivalent scientific degree.
Minimum 8 years of experience in pharmaceutical (chemical) manufacturing.
Experience in a global/matrix environment in the pharmaceutical industry. Comprehensive know how in pharmaceutical (chemical) technology, Project Management experience, Drug Development experience. Sound experience of data handling and applied statistics.
Strong technical and analytical problem‑solving capability.
Clear and effective communication with cross‑functional partners.
Ability to work efficiently within a global matrix environment.
Structured approach to documentation, compliance, and data analysis.
Proactive ownership of technical responsibilities within assigned scope. Ability to prioritize and manage multiple parallel activities. Strong decision‑making supported by scientific rationale.
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.
Skills Desired
Applied Statistics, Assembly Language, Change Control, Chemical Engineering, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Process and Cleaning Validation, Process Control, Process Simulation, Risk Management, Root Cause Analysis (RCA), Scientific Method, Six Sigma, Statistical Analysis, Technology Transfer
