Sr. Scientist ISr Scientist II, Documentary Standards (Complex Generics)

Who is USP

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds leading health and science experts to develop rigorous quality standards for medicines dietary supplements and food ingredients. At USP we believe that scientific excellence is driven by a commitment to fairness integrity and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1300 professionals across twenty global locations working to strengthen the supply of safe high-quality medicines worldwide.

At USP we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship professional development and leadership opportunities. Our partnerships standards and research reflect our belief that ensuring broad participation in scientific leadership results in stronger more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair merit-based selection processes that enable the best scientific mindsregardless of backgroundto contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

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 working in close collaboration with USPs Expert Committees.

How will YOU create impact here at USP

As part of our mission to advance scientific rigor and public health standards you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity regulatory excellence and evidence-based decision-making to ensure health systems worldwide can rely on strong tested and globally relevant quality standards.

Additionally USPs People and Culture division in partnership with the Equity Office invests in leadership and workforce development to equip all employees with the skills to create high-performing inclusive teams. This includes training in equitable management practices and tools to promote engaged collaborative and results-driven work environments.

The Senior Scientist I/II has the following responsibilities:

• Describe build and advance a vision and roadmap for Complex Generics with a focus on Inhalation products.
• Paticipate in cross-functional groups to focus efforts on specific knowledge domains and high-impact topics.
• Determine deliverables requirements and timelines for the development of standards and solutions for complex generics particularly inhalation products
• 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 inhalation product 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.
• Work closely with other USP departments to ensure Complex Generics related standards and solutions are known valued and used through various service offerings such as education and training consulting and lab services.
• Participate in internal and external capability-building activities related to Complex Generics including training education and knowledge-sharing across the organization.
• Other duties as assigned.

Who is USP Looking For

The successful candidate will have a demonstrated understanding of our mission commitment to excellence through inclusive and equitable behaviors and practices 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 ./ with a minimum of 11-13 years of relevant experience with USP-NF test and standards is required.

Senior Scientist - II:

• Ph.D. degree in Analytical Chemistry Organic Chemistry Pharmaceutical/Formulation or a related field and a minimum of 10-13 years or ./. with a minimum of 13-15 years of relevant experience with USP-NF test and standards is required.

• An equivalent combination of education and experience may substitute.
• Direct practical experience in the Complex Generics field in the pharmaceutical industry with a focus on inhalation products as well as other complex product expertise such as ophthalmics and /or complex injectables.
• In-depth knowledge of various product characterizations for inhalation products (meter dose inhalers nasal delivery devices dry powder inhalers and nebulizers) including particle size analysis spray pattern and plume geometry. Other expertise should include dissolution and permeability delivered dose and aerodynamic sizing fine particle fraction and others.
• Excellent written communication skills required with a focus on scientific writing for the pharmaceutical industry.
• Excellent verbal communications skills required including the ability to speak with authority and respect.
• Good interpersonal skills required including the ability to form strong relationships with team members and industry stakeholders.

Additional Desired Preferences

• Experience working with Inhalation generic drug product development and characterization methodologies.
• Working knowledge of CMC regulatory requirements for API and/or Finished Dosage Form development.
• Strong project management skills with ability to be effective both independently and in collaborative teams.
• Self-motivated and entrepreneurial.
• Known and respected within the pharmaceutical Complex Generics community.

Supervisory Responsibilities

None this is an individual contributor role.

Benefits

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

Required Experience:

Senior IC