The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years.
Post : Associate - Scientific Liaison-Chemical Medicines
Job Description
This is a non-supervisory scientific position in the Chemical Medicines Department (CM) reporting to Director/Team Leader. The role is that of an individual contributor. The incumbent is responsible for the development of monographs for small molecular-weight pharmaceuticals (drug substances and associated dosage forms) in the USP-NF and supports USP Expert Committees and associated Expert Panels. The department works closely with Reference Standards Evaluation (RSE) Compendial Development Laboratories (CDL) within Global Laboratory Organization (GLO) and other departments such as Publications (PUBS), Executive Secretariat and Compendial Affairs.
Roles and Responsibilities
- Develops new monographs and revises existing monographs based on supporting data submitted by USP global laboratories and external sponsors
- Evaluates analytical methodology and acceptance criteria
- Redesigns 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 agencies, 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 cross-functional 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, the pharmaceutical industry, trade organizations 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 Compendial Development Laboratories, Reference Standards Evaluation, Reference Standards Laboratories, Publications, Executive Secretariat, Compendial Affairs and other departments on monograph-related issues
- Tracks and reports frequently to management on the status of assignments
- Performs other duties as assigned
Candidate Profile
Scientific Liaison:
• Ph.D. in Chemistry, Biochemistry or allied field with a minimum of 8 years, or M.S. and 10 years of relevant experience with USP-NF tests and standards
• Minimum of 8 years of experience with analytical techniques such as chromatography, wet chemistry, spectroscopy, titration, etc.
• Knowledge of compendial standards related to pharmaceutical industry
• Knowledge of regulatory requirements and guidelines for pharmaceuticals (e.g. FDA, ICH, etc.)
• An equivalent combination of experience and education may be substituted
Associate Scientific Liaison:
• Ph.D. in Chemistry, Biochemistry or allied field with a minimum of 5 years, or M.S. and 7 years or B.S. and 10 years of relevant experience with USP-NF tests and standards
• Minimum of 5 years of experience with analytical techniques such as chromatography, wet chemistry, spectroscopy, titration, etc.
• Knowledge of compendial standards related to pharmaceutical industry
• Knowledge of regulatory requirements and guidelines for pharmaceuticals (e.g. FDA, ICH, etc.)
• An equivalent combination of experience and education may be substituted
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Preferred Qualifications:
• 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
Additional Information:
Experience: 5-7 years
Job ID : 939-679
Location: Rockville, Maryland, United States
Education: Ph.D. in Chemistry, Biochemistry
Industry Type: Pharma
Functional Area: Chemical Medicines
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