The U.S. Pharmacopeial Convention (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 brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide.
We are recruiting to fill the position of:
Job Title: Technical Officer, Chemistry, Manufacturing & Control (CMC)
Summary of the Position
- The Technical Officer, Chemistry and Manufacturing Control (CMC) will provide technical assistance to POM+ supported manufacturers to produce quality assured maternal newborn and child health (MNCH), nutrition and malaria medical products.
- The candidate must have expert skills in pharmaceutical manufacturing, dossier evaluations / submission and facility inspection. Assessment for compliance to Good Manufacturing Practice (GMP).
- S/he must understand the pharmaceutical development process from pre-clinical development through life cycle management.
- She will provide technical assistance to MRA in aspects of dossier evaluation and inspection of facilities for compliance to GMP.
- Have good understanding of pharmaceutical regulatory environment for pharmaceutical manufacturing.
Roles and Responsibilities
- Provides technical assistance to local manufacturer’s in-country to implement and comply with GMPs and in the development of dossiers to submit for WHO prequalification.
- Facilitate the development of quality management documentation in compliance with WHO guidelines.
- Build capacity on dossier compilation, GMP compliance, GxPs for staff and identified gaps in knowledge towards compliance on WHO guidelines,
- Conduct mock GMP inspection(s) in preparation for WHO P0, MRA/Regional body/Multilateral procurement agency inspections as welt as effective implementation of CAPA plans.
- Facilitate the development ol rn4ious training programs to ensure sustainability and knowledge transfer.
- May provide mentorship to staff as applicable
- Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports.
- Minimum of 6+ years of experience leading and implementing technical assistance programs in expanding access to global health products and pharmaceuticals.
- Bachelor's Degree in Pharmacy, Pharmaceutical Science Chemistry, Engineering, or Science related field of study required.
- Working understanding of Chemistry, Manufacturing and Controls, good manufacturing practice, dossier evaluation and inspection.
- Direct experience implementing USAlD4unded programs.
- Direct experience and understanding of WHOP pre-qualification process.
- Strong written (especially technical writing) and oral communication skills.
- Experience working with regional regulatory bodies and/or local manufacturers.
- Willingness to travel at least 25% of the time.
Preferred Qualification Required:
- Minimum of 3+ years of people managerial experience and skills
- Experience in at least one of the following health areas: HIV/AIDS, Malaria, TB, NTDs, AMR, MNCH
- Country the work is expected to be completed done: Nigeria.
Restrictions or Key Requirements for The position:
- Must be resident in Lagos
- Should be able to speak the local dialect fluently.
USP offers an impressive benefits and allowances package.
Application Closing Date
19th October, 2021 (4:00 PM).
Method of Application
Interested and qualified candidates should send their CV to: [email protected] using the Job Title as the subject of the email.
- USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class.
- We are committed to working with and providing reasonable accommodation to individuals with dieabilities.
- 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. It is PQM+ intent to grant this offer to the most suitable candidate.