Senior CMC Technical Advisor
Senior CMC Technical Advisor
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Job Description
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 highquality 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 meritbased 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 will expand capabilities in medical products manufacturing. The incumbent will be responsible for providing technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of qualityassured essential medical products. The incumbent will collaborate externally with donor regional stakeholders and partners. The incumbent will interface internally with USP departments and with the donor.
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 highquality medicines through public standards and related programs. USP prioritizes scientific integrity regulatory excellence and evidencebased decisionmaking 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 highperforming inclusive teams. This includes training in equitable management practices and tools to promote engaged collaborative and resultsdriven work environments.
The Senior CMC Technical Advisor has the following responsibilities:
Actively participate in annual programmatic and resource planning process and contribute to programmatic growth.
Actively participate in the planning and delivery of technical assistance and provide support to manufacturers and regulators to achieve the objective of increasing the supply of qualityassured essential medical products.
Provide technical assistance to manufacturers in GMP lead technology transfer and dossier development and submission.
The Senior Technical Advisor conducts GMP assessments/mock audits trainings and supports the deployment of tools and approaches to ensure the adoption of international manufacturing quality standards to achieve market authorization product registration and WHO prequalification.
Identify CMC risks and support the development of mitigation and contingency plans.
Work closely with other program technical teams to ensure the deployment of holistic implementation strategies.
Support the work and efforts of other technical teams at HQ and regional level; also plan and conduct product peerreviews as designated.
Keep abreast of the latest technologies in industry and regulatory requirements.
Participate in program thought leadership activities by contributing to white papers journal articles and representing the organization at global and regional conferences.
Represent USP and Program in local and regional forums on manufacturing.
Act as the Technical point of contact for designated technical areas; also represent the program in working groups and forums at the global and regional levels.
Act as recognized leader actively advancing and deploying new technologies and trends in manufacturing.
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:
BS MS or Ph.D. degree in pharmacy pharmaceutical science chemistry engineering or science related field of study required.
Minimum of 15 years of experience in medical products manufacturing.
Subject matter expert in manufacturing processes comparability / feasibility studies stability studies analytical development and regulatory filings.
Thorough understanding of Chemistry Manufacturing and Controls and Good Manufacturing Practices for medicines packaging and other relevant areas.
Minimum of 10 years of the experience in WHO prequalification of medical products and/or other regulatory authority registration processes.
Knowledge of regulatory requirements related to the development and manufacture of medicines in all phases of clinical development.
Direct experience with regulatory authority registration processes.
Strong written (especially technical writing) and oral communication skills.
Willingness to travel up to 25 of the time.
Additional Desired Preferences
Direct experience implementing donorfunded programs.
Minimum of 5 years people management experience and skills.
Experience in at least one of the following health areas: HIV / AIDS malaria TB MNCH.
Experience with including water systems sterility HVAC contamination analytical chemistry cleaning procedures validation formulations and other relevant areas.
Supervisory Responsibilities
None this is an individual contributor role.
Benefits
USP provides the benefits to protect yourself and your family today and tomorrow. From companypaid time off and comprehensive healthcare options to retirement savings you can have peace of mind that your personal and financial wellbeing is protected.
Compensation
Base Salary Range: USD $121000.00 $169750.00 annually.
Target Annual Bonus: Varies based on level of role.
Individual compensation packages are based on various factors unique to each candidates skill set experience qualifications equity and other jobrelated reasons.
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.
Required Experience:
Senior IC
Employment Type
Full-Time
