AS&T (Analytical Science & Technology) Manager

Responsibilities

• Acts as Single Point of Contact (SPOC) for all AS&T related activities at the assigned External Suppliers.
• Lead and implement global AS&T the requirements/programs in the assigned ESO QA Network and act as project lead in cross functional ESO AS&T project teams.
• Lead and own analytical method transfers (AMTs) process within ESO.
• Support the external suppliers selection process, qualification process and analytical trouble shooting as needed.
• Support the regulatory team in submissions, variations and other regulatory activities from an analytical perspective.
• Support assessments of analytical Change Control records for acceptability.
• Define studies needed to support the changes.
• Support Quality Assurance Manager (QAM) to define and maintain the ESO Stability Program at CMOs and ensure that Stability Programs are state-of-the-art with respect to HA requirements and in line with registration documentation.
• Provide corrective actions to address emerging stability issues.
• Support QAM in analytical results investigations (e.g. OOS), complaints that require analytical interpretation.
• Support defining and implementing business processes and SOPs/GOPS necessary to maintain a robust AS&T Quality System within External Supply.
• Support the QAM in product investigations and assure that they are managed in agreement with Sandoz standards.
• Responsible for implementing effective CAPAs at the suppliers/contract labs.
• Support QAM to ensure Testing Monographs are state-of-the-art with respect to technique and technology and in line with registration documentation.
• Responsible SPOC for implementation of compliance alerts for analytical methods / monographs.
• Provide support for site readiness for Health Authority inspections as required.
• Participate in audits/technical visits on request as an SME.

Requirements

• Advanced university degree (Master’s or equivalent) in Natural Sciences (Chemistry, Pharmacy, Biotechnology, Biology).
• Minimum of 8 years’ experience within the pharmaceutical industry in quality control or analytical development that includes method development, method validation, stability testing, method transfers.
• Expertise in different analytical techniques required.
• Thorough knowledge of cGMP requirements, ICH guidelines, major pharmacopeial requirements, regulatory requirements.
• Excellent communicator in both English and Mandarin, with advanced negotiation skills.

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 are 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!

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.