Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!
To serve as the primary technical interface between Sandoz Manufacturing sites and the Global MS&T Capability Hub, offering expert guidance on manufacturing process design, validation strategies, and resolution of complex technical issues. The Technical Expert ensures robust process performance, product quality, and regulatory compliance across the product lifecycle, while enabling efficient technology transfers and driving continuous improvement. This role supports both internal and external manufacturing networks, contributing to strategic decisions and operational excellence.
The Technical Expert also supports ESO Technical Managers in conducting technical due diligence during the pre-evaluation phase, in collaboration with BD&L, to help identify suitable external suppliers. The role contributes to the preparation and review of related documentation.
Additionally, the Technical Expert facilitates product transfers for both legacy and new development productsfrom Sandoz Development to internal manufacturing sites, external suppliers, or between suppliers. They align with Development teams during early-stage process design and support associated documentation. The role provides technical and scientific support to Supply Relationship Teams (SRTs), working closely with QA Managers, Site Change Coordinators, and Supply Relationship Managers to evaluate compliance activities such as deviations, change controls, complaints, and CAPAs. It ensures smooth knowledge and information flow across functions, with a focus on process and product expertise.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Technical Support to internal Manufacturing Sites and CMOs:
- As a Technical Expert to the assigned manufacturing site internally or CMO, ensure and improve product process capability, to keep the knowledge of process up to date and to maintain the product in constant state of validation.
- Implement Science- and Risk-based approaches to ensure that product quality can be sustainably reproduced.
- Ensure the availability of all relevant Technical Documentation such as protocols, reports, Risk Assessments, Concept papers, Scientific Justifications based on significant body of information generated regarding the product & the process ahead of the planned activities at the respective sites
Product/Technical Stewardship for assigned sites:
- Act as Technical Expert to maintain the oversight and knowledge for entire manufacturing process throughout the entire commercial lifecycle at given internal Mfg site/ external suppliers.
- Ensure a proper understanding of manufacturing process and influencing factors (i.e. CQAs, CMAs and CPP) to ensure product quality and process robustness at the commercialization site.
- Analyze product-specific manufacturing data from OPV Reports/CPV Reports/APQRs and other relevant sources where needed and agree on state of control
- Assess impact of technical changes, assess technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of proposed technical changes.
- Contribute to the registration strategy and ensure alignment of (regulatory) timelines for technical changes, transfers, launches and/or major deviations.
- Lead / support the assigned sites on the root cause investigation of product and process failures.
- Effectively liaise with the CMOs to initiate and lead/support product / process remediation / improvement activities, involving cross-functional teams and with clear interfaces to Quality, Operations, Engineering and Technical Development.
- Maintain Division and/or cross-division networks to share lessons learned and best practices related with process and technologies.
Validation Support for product(s) /Sites assigned:
- Responsible for the validation oversight and for maintaining the product in constant state of validation.
- Challenge defined control strategy based on CQA and where necessary on CPP, CMA. prior to validation and for defined improvement projects
- Review respective Quality Risk Analysis (QRA) prior to validation for technical changes.
- Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters.
- Review validation protocol and report as appropriate.
- Provide all necessary information to generate the validation documentation.
- Support Validation Lead and Experts to assess need and plan validations, assess revalidation need.
Launch & Transfer Support
- Participate in external supplier / product evaluation and selection process. Responsible for gathering technical information on manufacturing process capability at the site/external supplier.
- Provide the necessary data for the technical activities involved in Tech Transfer of a product through the appropriate documentation, focusing on existing knowledge. Support technical activities at the giving / receiving site as needed.
- Define product acceptance criteria for the transfer, agree on acceptable performance with receiving organization and monitor routine manufacturing performance following transfer
- Ensure successful and well-documented transfers and launches of products with external manufacturing involvement.
- Active support for Product Launch and Transfer governance processes
Interface to Development for the product(s) /Sites assigned:
- Ensure that new products and processes are well developed for the commercial scale and the entire product lifecycle at the commercialization site
- Provide input to formal stage gates during development and up to first OPV/APR/PQR as part of the development process to ensure early integration and to ultimately meet manufacturing requirements
- Support development of comprehensive control strategy early on in the development to ensure that validation requirements meet regulatory requirements and other critical metrics (e.g., quality, safety, environmental, cycle times, etc.).
Manufacturing & Operational Excellence for defined product(s) /Sites assigned:
- Define and execute design and control optimization projects where needed.
- Provide SME expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability.
- Demonstrates the capability and willingness to prepare high-quality design and operational documents, and proactively takes on challenging projects driven by evolving regulatory requirements, audits, and compliance needs.
What you'll bring to the role:
Minimum Requirements:
Education (minimum/desirable):
- Bachelors/Masters. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
- Desirable PhD.
Languages:
Fluent in English & Local Language of the respective Country.
Relevant Experiences:
- 8- 12 years of experience in pharmaceutical (chemical) manufacturing.
- Drug Development experience
- Sound experience of data handling and applied statistics
- Proven experience in process development, scale-up principles, and technical investigations.
- Strong knowledge of regulatory guidelines: USFDA, EMA, ICH, ASTM, SUPAC.
- Expertise in QbD, DoE, Minitab, and statistical analysis.
- Ability to prepare high-quality design and operational documents for equipment qualification, verification, and continuous process validation.
- Excellent communication and cross-functional collaboration skills.
- Ability to manage multiple complex projects in a global matrix environment.
You'll receive:
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit 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, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
#Sandoz
