The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Post : Senior Scientist I, Documentary Standards (Reviewer)
Brief Job Overview
This is a hands-on, non-supervisory scientific position the Global Biologics department. The incumbent is responsible for providing support for the development of USP documentary standards and reference standards for biological products such as peptides, Oligonucleotides, protein, carbohydrates, Complex Biologics, Vaccines, Antibiotics, and advanced therapies. The incumbent will provide quality and technical review of scientific documents for accuracy, clarity and compliance, manage and track reference standard stability program and organize efforts for continuous process improvements. The incumbent will also focus on supporting the reference standard suitability program, including preparing and reviewing CSU testing protocols, providing technical assistance to testing labs, reviewing analytical data and preparing summary reports for confirming the continued suitability of USP Reference Standards (RS). The incumbent need to be excellent team player with good collaboration/Liaising skills to complete assigned projects in time-bound manner.
Roles and Responsibilities
• Performs technical and quality reviews of documents to ensure a high level of document quality and compliance before QA review
• Manages and tracks efforts for continuous process improvements.
• Develops and reviews SOP’s, Operation Manuals, and training documents.
• Assists in investigations of quality related issues resulting from customer complaints to include root cause analysis, corrective action identification, action planning, and implementation monitoring.
• Supports the day to day operation of the reference standard stability program.
• Works with internal stakeholders to develop new and innovative standards for analytical analysis of biological products.
• Communicates and maintains working relationships with cross functional USP departments regarding assigned projects
• Supports day to day operations of the RS Stability (CSU) program covering the USP Biologics RS catalog inventory.
• Reviews RS testing history and drafts test protocols for CSU studies and submits to labs based on designated testing requirements and schedules.
• Liaisons and Assists laboratories to ensure CSU testing is completed as per protocol and in timely manner.
• Reviews laboratory reports, evaluates results and compares to previous data and RS attributes to assess and conclude on RS suitability for use.
• Compiles, assess current and historical stability testing data and prepare stability trend reports in a time-bound manner.
• Support the maintenance and updation of various databases documenting laboratory data and program determinations on suitability and Stability interval updates.
• Filing and closure of QMS elements as per QMS system when required and supports the RS Laboratory, Supporting Quality Assurance and Reference Standard Evaluation in the investigation of unexpected stability testing results
• Works collaboratively with various USP departments as needed on test planning, data impact assessments and appropriate determination of next steps.
• Prepare, present and discuss regular work updates with Team Lead and other team members
Candidate Profile
• PhD. degree in Biochemistry/Biology/Pharmacy, or a related field Minimum of 7 to 10 years, or Masters degree in Biochemistry/Biology/Pharmacy or a related field with 11 to13 years of years of commensurate industrial experience.
• Demonstrated experience in Techical review of analytical documents in Quality Assurance.
• Hands-on experience with state-of-the-art analytical techniques for the characterization of recombinant therapeutic proteins, peptides, gene therapy, vaccines and carbohydrates, such as UPLC/HPLC, LC-MS, CD, Fluorescence spectroscopy, FTIR, DSC, SEC-MALS, CE-SDS (Reducing and Non-reducing), icIEF, ELISA, SPR, ddPCR/qPCR etc.
• Strong ability to evaluate and compile analytical testing data, ability to write technical reports related to material characterization, references standard evaluations, and method development.
• Demonstrated experience in analytical method development, method qualification/validation and characterization of biological products and impurities using a variety of physicochemical techniques and biological assays.
• Excellent technical writing, presentation and oral communication skills are required.
• Must be excellent team player and able to work amicably and communicate effectively with both internal and external stakeholders.
• Knowledge of USP products and services is highly desirable.
• Operates collaboratively at all levels of the organization in a highly technical environment.
• Must be able to work in a fast-paced environment and respond to shifting priorities.
• Well-developed interpersonal, negotiation, conflict-resolution and listening skills.
• Must possess the ability to multi-task and to work effectively with a team.
• Takes ownership and personal responsibility to ensure work is delivered on time and is of the highest possible quality.
• Experience working in the compendial, pharmaceutical and/or biotechnology industry strongly preferred.
Additional Information
Experience : 5+ years
Qualification : Masters degree or Ph.D
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Documentary Standards
End Date : 15th August 2025
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