Senior Scientist I, Documentary Standards

2 days ago


Hyderabad, Telangana, India US Pharmacopeia Full time ₹ 20,00,000 - ₹ 25,00,000 per year

You will be joining USP's Global Biologics department as a Sr. Scientist - I (RSS-Review), where you will play a crucial role in supporting the development of USP documentary standards and reference standards for biological products. In this hands-on, non-supervisory position, you will be responsible for ensuring the accuracy, clarity, and compliance of scientific documents, managing the reference standard stability program, and driving continuous process improvements. - Performing technical and quality reviews of documents - Developing and reviewing SOPs and training materials - Assisting in investigations of quality-related issues - Collaborating with internal stakeholders to develop new standards for analytical analysis of biological products - Maintaining the reference standard stability program - Reviewing testing data, preparing stability trend reports, and updating databases to document laboratory data and program determinations To succeed in this role, you must have: - A PhD degree in Biochemistry/Biology/Pharmacy or a related field with 7 to 10 years of experience, or a Master's degree with 11 to 13 years of experience - Demonstrated expertise in technical review of analytical documents in Quality Assurance - Hands-on experience with analytical techniques for characterizing biological products - Strong communication skills, both written and verbal - Ability to work collaboratively with internal and external stakeholders USP is committed to providing comprehensive benefits to protect the well-being of you and your family, including paid time off, healthcare options, and retirement savings. By joining USP, you will contribute to the organization's mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs.,



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