Senior Scientist I, Documentary Standards (Reviewer) US Pharmacopeia

7.0 - 13.0 years

0 Lacs

hyderabad, telangana

On-site

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. Your primary responsibilities will include performing technical and quality reviews of documents, developing and reviewing SOPs and training materials, assisting in investigations of quality-related issues, and collaborating with internal stakeholders to develop new standards for analytical analysis of biological products. You will also be involved in 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. You should have demonstrated expertise in technical review of analytical documents in Quality Assurance and hands-on experience with analytical techniques for characterizing biological products. Strong communication skills, both written and verbal, along with the ability to work collaboratively with internal and external stakeholders, are essential for this position. Additionally, knowledge of USP products and services, experience in the pharmaceutical or biotechnology industry, and the ability to work effectively in a fast-paced environment are desired preferences. While there are no supervisory responsibilities associated with this role, you will be expected to take ownership of your work, ensure timely delivery of tasks, and maintain the highest quality standards. 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.,

Posted 5 days ago

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