Donation Review Scientist II / III

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

The Donation Review Scientist II / III is a hands-on, non-supervisory position in the Regions & Program Operations reporting to the Director, Standards and Program Integration. The incumbent is responsible for the review, processing, and delivery of high-quality monograph donations to science for monograph proposal development, which are critical to USPs standards pipeline. Through this process, the incumbent will be required to conduct thorough reviews, engage, and follow up with donors, and collaborate with regional USP staff/Science to ensure all necessary materials and documents are provided. Other responsibilities include contributing to Regions & Program Operations Division projects and initiatives as assigned.

How will YOU create impact here at USP?

• Perform an in-depth review of incoming donation materials for completeness and suitability.
• Appropriately update internal systems with notes and donation stages.
• Triage/categorize USP Revision Requests to ensure efficient and effective delivery to science.
• Conduct donor follow-ups to obtain any missing information.
• Ensure the timely delivery of complete data packages to USP scientific staff for development into a documentary standard or to revise a currently official standard.
• Collaborate with the source of a potential monograph as needed, offering scientific expertise and guidance related to USP processes.
• Support and engage Scientists, reference standards scientists, reference standards procurement specialists, and other staff in the development process (as needed).
• Use knowledge of analytical chemistry to review monograph submissions.
• Work closely with donation operations and engagement staff responsible for obtaining of quality monograph donations.
• Work closely with a team of impactful scientists responsible for the development and revision of documentary standards.
• Work with USP other staff, regulatory agencies and collaborators, and other stakeholders as related to monograph development, as needed.
• Participate in the collaborative prioritization of monograph donations for the internal/external standard pipeline.
• Manage multiple donations with competing interests, ensuring high quality deliverables are produced in a timely manner.
• Engage donors to ensure a smooth and seamless donor experience. Leverage insights to continue driving the donor experience.
• Operate within a best practices framework, driving to consistency in process, operations, data, and systems use.
• Support cross-departmental and cross-divisional activities as assigned.
• Recognize and escalate issues and ideas potentially requiring upper management awareness and input. Perform other duties as assigned.

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, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

Donation Review Scientist II

• Bachelors degree in Chemistry or another scientific field.
• Minimum of five (5) years of relevant professional experience in Technical Service or
• Analytical Method Development areas of pharmaceuticals.
• Experience using analytical techniques such as chromatography, wet chemistry, spectroscopy, titration in a laboratory setting.
• An equivalent combination of experience and education may be substituted. Advanced computer competence (MS Office programs).

Donation Review Scientist III

• Eight (8) years of relevant professional experience in Technical Service or Analytical Method Development areas of pharmaceuticals.
• Experience using analytical techniques such as chromatography, wet chemistry, spectroscopy, titration in a laboratory setting.
• An equivalent combination of experience and education may be substituted.
• Masters degree is desirable. Combination equivalent of degree/years experience accepted.

Additional Desired Preferences

• Familiarity with USP monographs and the USP revision process
• Proficiency with Microsoft Office, data query, analysis, and reporting.
• Knowledge of or experience with Salesforce (or CRM) and/or Tableau desired.
• Excellent presentation, written, and verbal communication skills, with audience appropriate awareness.
• Superior interpersonal skills: professionalism, collaboration, accountability, delegation, and customer service.
• Ability to build effective work relationships quickly and work collaboratively in a global setting both internally and externally.
• High business acumen abilities - can understand and deliver on business objectives.
• High comfort with navigating through ambiguity and frequent change, and course- adjusting in the moment.
• Strong time management skills.
• Strong organizational skills and attention to detail.

Supervisory Responsibilities

None, at this time.

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 workfrom 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)

Job Category Chemistry & Scientific Standards

Job Type Full-Time