U.S. Pharmacopeial Convention Jobs

Job Information

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

Description

Who is USP?

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts 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 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

Brief Job Overview

This position is a non-supervisory hands-on, highly technical role that supports the standard-setting activities of the USP-NF. The incumbent is responsible for revising and developing new USP standards and standards associated with complex generics and complex excipients working in close collaboration with USP’s Expert Committees.

How will YOU create impact here at USP?

  • 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.

Who USP is Looking For?

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.

Supervisory Responsibilities

No.

Benefits

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.

COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):

As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Job Category Chemistry & Scientific Standards

Job Type Full-Time

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