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 : Senior Scientific Liaison - Chemical Medicines
Job Description
This is a non-supervisory scientific position in the Monograph Modernization - Chemical Medicines Department (MM-CMD) reporting to Director. The incumbent is responsible for the development and revision (modernization) 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. The supporting data for monograph modernization are based on internal sponsor (USP laboratories).
The department works closely with the External sponsor- Chemical Medicines Department (CMD, Reference Standards (RS), Monograph Research & Development (MRD) within Global Science & Standard Division (GSSD) and other departments such as Publications (PUBS) and Executive Secretariat & Project Management (ES & PM).This department also works closely with the others in the department and division, particularly USP’s laboratories and reference standard development scientists
Roles and Responsibilities
- Develops new monographs and modernizes existing monographs based on internal supporting data submitted by USP global laboratories.
- Evaluates monograph tests, procedures and acceptance criteria;
- Redesign existing official monographs;
- Works closely with a team of high-performing scientists responsible for the development and revision of documentary standards;
- Works with USP staff, regulatory bodies, stakeholders, and other pharmacopeias as related to monograph development;
- Provides information to the relevant USP Expert Committee(s) in support of monograph development;
- Serves as a mentor for other staff and leads training efforts, as needed;
- Serves as a member on USP teams, as needed;
- Prepares manuscripts for publication by USP (e.g., stimuli articles) or in peer-reviewed journals;
- Represents USP at scientific conferences/meetings, outreach visits and other events sponsored by USP and/or pharmaceutical industry and regulatory agencies;
- Participates in the development and/or review of USP’s professional education course materials and may serve as an instructor, as needed.
- Collaborates closely with MRD, CMD, RS, RSO, PUB and ES& PM on monograph-related issues;
- Tracks and reports frequently on the status of assignments to management;
- 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. in Chemistry, Biochemistry or allied field with a minimum of 10 years.
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: 10 years
Qualification: Ph.D
Tracking Code: 817-679
Location: Hyderabad, Andhra Pradesh, India
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Non-supervisory scientific
End Date: 15th March, 2017
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