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 II, Documentary Standards
Job Description
Brief Job Overview
This position is a non-supervisory hands-on, technical role that supports the standard-setting activities of the USP-NF. The incumbent is responsible for revising and developing new USP-NF monographs for drug substances and drug products working in close collaboration with USP’s Small Molecules Expert Committees and our volunteers.
• Oversees and facilitates all aspects of the development of documentary Standards for the USP-NF. Evaluates and analyzes supporting data and converts into USP style and format.
• Collaborates with stake holders and sponsors for development of Documentary Standards.
• Assists in the activities of the USP Expert Committees and Expert Panels, as needed.
• Communicates and collaborates with USP departments on documentary standards development topics.
• Participates in the development and/or review of USP’s professional education course materials and may serve as an instructor.
• Provides general scientific-related support to other scientific and managerial staff.
• Responds to inquiries pertaining to USP-NF monographs and General Chapters.
• Writes general and specific subject correspondence pertaining to USP standards.
• Keeps abreast of current trends and developments in related scientific fields.
• Communicates and collaborates with USP Laboratories regarding projects related to validation studies, method development, and reference standards.
• Serves as representative of USP at professional meetings (scientific meetings organized by USP and other organizations, meetings at other pharmacopeias or regulatory agencies etc.). Gives public presentations on USP matters (as assigned)
• Performs other related duties as required.
Candidate Profile
Senior Scientist I : MSc with minimum 11 to 13 years relevant experience; or Ph.D. degree in Chemistry, Biochemistry, or a related scientific field with 7 to 10 years.
Senior Scientist II : MSc with minimum 13 to 15 years relevant experience; or Ph.D. degree in Chemistry, Biochemistry, or a related scientific field with 10 to 13 years
• Broad pharmaceutical industry experience in CMC development of active pharmaceutical ingredients and drug products.
• Experience authoring reports used for ANDA/NDA or product applications for global submissions a plus.
• Strong knowledge regarding the development, validation, and application of modern analytical techniques to the testing of pharmaceuticals.
• Knowledge of global regulatory requirements and guidance (e.g. FDA, ICH, etc.) relevant to pharmaceutical products
• Able to lead and coordinate high performing cross-functional teams. Able to prioritize tasks and manage multiple projects simultaneously.
• Able to distill large amounts of information into executable strategies and workplans.
• Able to adapt landscapes, strategies, and workplans based on organizational/stakeholder needs and constraints.
• Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.
• Must be able to share technical information with non-technical or non-scientific staff, and to communicate effectively with representatives from pharmaceutical companies, government, and academic institutions.
• Able to establish and nurture relationships with individuals of varying backgrounds, cultures and learning styles.
• Able to operate independently yet understands when to escalate issues and how to establish effective working relationships.
• Strong presentation and communication skills (written and oral).
• Expertise in site-to-site transfer of methods and method equivalency.
• Experience with advanced manufacturing technology (AMT), process analytical technology (PAT) a plus.
• Experience with the development and/or commercialization of complex generics products a plus.
• Expert knowledge of organic chemistry especially with regards to formation of impurities a plus.
• Expert knowledge on risk assessment and the establishment of control strategies for all classes of impurities in pharmaceutical drug substances and drug products a plus.
Additional Information
Experience : 5+ years
Qualification : MSc or Ph.D. degree in Chemistry, Biochemistry
Location : Hyderabad, IND
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Documentary Standards
End Date : 10th November 2024
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