AS&T Manager, Large Molecules. (Hyderabad)

AS&T Manager, Large Molecules. (Hyderabad)

13 Aug
|
Sandoz
|
Hyderabad

13 Aug

Sandoz

Hyderabad

Job Description Summary
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 current and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape

Join us as a Analytical Science & Technology (AS&T;) Manager in ESO Injectables organization within STO Large Molecules & Injectables Platform.

Job Description
Your Key Responsibilities:
Your responsibilities include, but not limited to:
- Acts as Single Point of Contact (SPOC) for all AS&T; related activities at the External Suppliers, specifically for GLP-1 product family.
- 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 Injectables function. 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.
- 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 interpretation. Support defining and implementing business processes and SOPs/GOPS

📌 AS&T Manager, Large Molecules. (Hyderabad)
🏢 Sandoz
📍 Hyderabad

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