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 1,100 hardworking professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Post : Scientist IV, Compendial Development Laboratory
Job Description
Brief Job Overview
This is a non-supervisory position in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The incumbent will be responsible for performing analytical method development and validations for USP/NF monographs and maintaining safety and GLP environment in the lab. This position is a component of USP’s core business, and the incumbent is expected to support monograph modernization initiatives.
• Engage in project planning, execution, method development and validation of projects according to set standards as USP general chapters, guidelines, SOPs and protocols.
• Apply technical and scientific expertise in analytical method development and validation of pharmaceuticals.
• Prepare and review the project plans, reports, laboratory notebook/ Laboratory management system (LMS) and compile project data as per requirement.
• Adhere to GLP and safety practices while working in the Lab.
• Practice Diversity, Equity, Inclusion, and Belonging principles at USP India.
Candidate Profile
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
• Master’s Degree in Chemistry (Analytical/Organic) or Pharmaceutical Sciences with 8-10 years of experience.
• Possess a fine understanding of USP/NF monographs/general chapters/general notices.
• Exposure to GMP/GLP/QMS environment and documentation procedures and champions the data integrity.
• Should be capable of performing analytical method developments and method validations using modern techniques and protocols.
• Good analytical skills in handling method development and Validations for Drug substances and Drug products.
• Should have exposure to GMP/GLP environment and documentation procedures.
• Awareness of ISO/IEC 17025 is desirable.
Additional Desired Preferences
• Master’s Degree in Chemistry (Analytical/Organic) or Pharmaceutical Sciences with 8-10 years of experience or Ph.D. with at least 4-7 years of experience in relevant field.
• Exceptional breadth of pharmaceutical industry experience.
• Excellent technical writing and oral communication skills required.
• Must be able to communicate effectively with diplomacy and enthusiasm.
• Technical and analytical skills required including the ability to interpret technical information.
• Must have hands on experience in working with chemical methods and handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, IC, ICP-OES/MS, FTIR, UV-Visible.
• Should have good understanding of GLP regulations and exposed to external regulatory audits.
Additional Information
Experience : 5+ years
Qualification : Ph.D, M.Pharm, MSc
Location : Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
End Date : 15th November, 2023
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