Technical Officer, Chemistry, Manufacturing & Control (CMC) at US Pharmacopeial Convention (USP)

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.

Basic Qualifications

• 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.

Remuneration
USP offers an impressive benefits and allowances package.