The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries
Post : Principal Scientific Liaison, Monograph Development
Job Description
This is a non-supervisory scientific position in the Chemical Medicines Department reporting to Director. The incumbent is responsible for the development and revision of monographs for small molecular weight pharmaceuticals (drug substances and the associated dosage forms) in the USP-NF and supports USP Expert Committee and associated Expert Panels.
These activities require critical evaluation of relevant documents and other information, performance of searches of regulatory and compendial sources, and the development and drafting of pertinent documents for the Expert Committee(s) review. The incumbent works closely with other liaisons in the Small Molecules Monograph Developments Group and in the General Chapter Group, with Reference Standards Lab (RSL), Reference Standards Evaluation (RSE), Research and Development (R&D) Lab, Project and Portfolio Management (PPM), Standards acquisition (StAcq), Compendial affairs and EC support within Global Alliance and Organizational Affairs (GAOA) and Publications (PUBS). The incumbent also works closely with the global pharmaceutical industry, regulatory authorities, the Council of Experts and other stakeholders to develop and modernize public standards for drug substances and drug products, and stays abreast of new developments in analytical chemistry and pharmaceutical quality methodologies
Roles and Responsibilities
- Works with USP Expert Committee(s), subcommittees, and expert panels, staff, and management, external stakeholders, and other pharmacopeias and regulatory bodies on activities related to chemical medicines monograph development, update and modernization.
- Develops new monographs, revises and updates existing monographs of the assigned monograph portfolio. Performs detailed and critical review of monograph submissions, evaluates monograph tests, procedures and acceptance criteria, translates specifications into USP–NF style and format.
- Works closely with a team of high-performing scientists responsible for the development and revision of documentary standards and allied Reference materials; participates in the laboratory protocol development for R&D and EPE projects.
- Shows commitment to quality. Leads the innovation and implementation of new processes and technologies that allow for continuous improvement. Identifies and resolves problems in a timely manner.
- Participates in the development and/or review of USP’s Global Education and Training professional education course materials and workshops and may serve as an instructor.
- Represents USP at scientific conferences/meetings, outreach visits and other events sponsored by USP and/or pharmaceutical/excipient industry and regulatory agencies and provides scientific expertise at internal and external meetings, scientific symposia, industry forums, and Expert Committee meetings.
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Performs other duties as assigned.
Required Skills
- Able to establish and nurture relationships with individuals of varying backgrounds and learning styles.
- Able to operate independently where appropriate, yet understands when to escalate issues and how to establish effective working relationships.
- Strong presentation and communication skills (written and oral).
- Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.
- Knowledge of internet and electronic database searches helpful.
- Practical experience in scientific, analytical techniques.
- Project Management skills required. Knowledge of the pharmaceutical industry and the associated regulatory framework is essential.
- Ability to prioritize tasks and manage multiple projects simultaneously.
- 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.
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Required Experience
Ph.D. or MS in Chemistry, Biochemistry or allied field with a minimum of 13 years of relevant experience with USP-NF test and standards required.
Minimum of 8 years of experience with analytical techniques such as chromatography, wet chemistry, spectroscopy, titration, etc. required.
Knowledge of compendial standards related to pharmaceutical product/industry also required as is knowledge of regulatory requirements and guidelines for pharmaceuticals (e.g. FDA, ICH, etc).
An equivalent combination of experience and education may be substituted.
Additional Information:
Experience: 13 years
Qualification: Ph.D or M.Sc
Tracking Code: 816-679
Location: Hyderabad, Andhra Pradesh, India
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Non-supervisory scientific
End Date: 25th January, 2017
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