Recruitment of Senior Scientist II, Documentary Standards at U.S. Pharmacopeial Convention

The U.S. Pharmacopeial Convention (USP) 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 : Senior Scientist II, Documentary Standards (Complex Generics & Excipients )

Job Description
* Lead internal and external cross-functional groups to focus efforts on specific knowledge domains and high-impact topics related to complex generics and complex excipients.
* Determine deliverables, requirements, and timelines for the development of Complex Generics and complex excipient standards and solutions.
* Execute against the standards and solutions roadmap through tight integration of activities within USP and with external stakeholders, including but not limited to industry, academia, and regulators.
* Advocate for Complex Generics development to support the generic pharmaceutical industry and use of USP standards and solutions across the broader scientific and regulatory communities.
* Maintain awareness of the current trends and issues in the industry by attending scientific seminars, conferences, industry consortia meetings, and other fora.
* Represent USP science and standards at industry conferences and symposia as well as through written articles.
* Lead internal and external Complex Generics and Complex Excipient capability-building activities, including training, education, and knowledge-sharing across the organization.
* Assist in the activities of the USP Expert Committees and Expert Panels, as needed.
* Communicate and collaborate with USP laboratories regarding projects related to validation studies, method development, and reference standards.
* Perform other related duties as required.

Candidate Profile:
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, and ability to quickly build credibility with stakeholders, along with the following competencies and experience:

Experience required:
Senior Scientist - I:
* Ph.D. degree in Organic, Analytical, Pharmaceutical/Formulation, or a related field and a minimum of 7-10 years, or M.Sc./M. Pharm with a minimum of 11-13 years of relevant experience with USP-NF test and standards required.
* Minimum of 5 years of experience with Complex generic formulation development and analytical testing (Injectables, ophthalmic, topical, or transdermal, Inhalation, and other complex formulations) working in the pharmaceutical industry. Specific expertise dealing with complex excipients including polymeric excipients.
Knowledge of various analytical testing procedures and methodologies in formulation, product development, and regulatory knowledge (FDA, ICH, etc.) for approval of pharmaceutical products.

Senior Scientist - II:
* Ph.D. degree in Organic, Analytical, Pharmaceutical /Formulation, or a related field and a minimum of 10-13 years, or M.Sc./M. Pharm. with a minimum of 13-15 years of relevant experience with USP-NF test and standards required.
* Minimum of 5 years of experience with Complex generic formulation development and analytical testing (Injectables, ophthalmic, topical or transdermal, Inhalation, and other complex formulations) working in the pharmaceutical industry. Specific expertise dealing with complex excipients including polymeric excipients.
* Knowledge of various analytical testing procedures and methodologies in formulation, product development, and regulatory knowledge (FDA, ICH, etc.) for approval of pharmaceutical products.

Additional Desired Preferences
* Able to establish and nurture relationships with individuals of varying backgrounds and learning styles.
* Able to operate independently where appropriate yet understand 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 the internet and electronic database searches helpful
* Practical experience in scientific and analytical techniques, formulation, product development, and manufacturing methodologies
* Project Management skills required.
* Knowledge of the excipient and pharmaceutical industries and the associated regulatory framework is essential. Ability to prioritize tasks and manage multiple projects simultaneously.
* Ability to work in a fast-paced environment with changing deadlines and priorities.
* 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.