AS&T (Analytical Science & Technology) Manager

Job Description Summary

Job Description

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!

We are looking for a proactive well-connected colleague to join our team as an AS&T (Analytical Science & Technology) Manager. In this role you will oversee Analytical Product Stewards ensuring strong analytical support across product lifecycle activities. Your contribution will directly support the Sandoz purpose by enabling reliable supply and patient access to high-quality medicines.

Your responsibilities include but not limited to:

• 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 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 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.
• Support interpreting stability data trends and provide scientifically sound conclusions for product shelf-life assessments storage conditions packaging and transport categories. Provide corrective actions to address immerging stability issues.
• Support QAM in analytical results investigations (e.g. OOS) complaints that require analytical defining and implementing business processes and SOPs/GOPS necessary to maintain a robust AS&T Quality System within External 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 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 / support for site readiness for Health Authority inspections as required. Participate in audits/technical visits on request as an SME.

Role Requirements:

• Education: Advanced university degree (Masters 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.

#Sandoz

Skills Desired