Senior Technical Officer – CMC in Dhaka, Bangladesh
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
The Promoting the Quality of Medicines Plus (PQM+) program, funded by USAID and implemented by USP, improves access to quality-assured priority medicines and addresses the proliferation of poor-quality medical products in low- and middle-income countries. PQM+ will strengthens medical product quality assurance systems through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system. By sharing scientific expertise and providing technical support and leadership, PQM+ helps create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as improves maternal, newborn and child health.
The Senior Technical Officer – Chemistry, Manufacturing and Controls (CMC) will have expert skills in pharmaceutical manufacturing and authoring the CMC sections of regulatory submissions. They must possess a deep understanding of the pharmaceutical development process from pre-clinical development through life cycle management. The selected candidate will engage with and leads all technical support provided to pharmaceutical manufacturers in Bangladesh. As the lead for PQM+ pharmaceutical manufacturing activities in Bangladesh, the Senior Technical Officer provides technical oversight related to the program’s objective of increasing the supply of quality-assured, essential medical products, including provision of technical assistance to manufacturers (including, GMP, Dossier development and submission). Additionally, S/he acts is a recognized leader, interfacing with DGDA and stakeholders involved in supplying and manufacturing essential medicines.
Roles and Responsibilities
Provides technical oversight of activities to support local manufacturers in Bangladesh
Leads in the delivery of trainings at regional and country level
Provide oversight for local CMC staff, local partners and consultants involved in delivery of manufacturing support
Work closely with country teams to support development and deployment of strategies in pharmaceutical sector development
Keep abreast of the latest analytical technology in industry and regulation requirements
Technical POC at regional and country level such as Bangladesh Association of Pharmaceutical Industries (BAPI)
Manages and mentors junior technical staff
Recognized leader in the Bangladesh pharmaceutical sector actively advancing and deploying new technologies and trends in pharmaceutical manufacturing
Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports
Masters’ degree in Pharmacy (M. Pharm), pharmaceutical science, chemistry, engineering or science related field of study required
Extensive [8 + years] experience leading and implementing technical assistance programs in expanding access to global health products and pharmaceuticals
Substantive [3+ years] people management experience and skills
Direct experience implementing USAID-funded programs
Working understanding of Chemistry, Manufacturing and Controls and Good Manufacturing Practices
Strong written (especially technical writing) and oral communication skills
Willingness to travel at least 25% of the time.
Direct experience with and understanding of WHO pre-qualification process
Experience at least one of the following health areas: HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH
Reports will scale with program growth and will include relevant technical staff
USP Acumen: Can explain USP’s mission, organization and strategy in the context of the role, as well as policies, practices, and trends impacting USP and its stakeholders.
Interpersonal Savvy: The ability to apply varying social skills across diverse situations to increase impact with people of different backgrounds and styles.
Relationship Building: Regularly invests time in initiating and sustaining relationships with colleagues and external stakeholders to drive results
Influencing Others: Able to communicate a unique individual perspective in a way that impacts others’ thinking.
Innovation: Motivated to incorporate new ideas and thinking to everyday problems.
Results Orientation: Consistently delivers on goals and deadlines while maintaining a high level of quality and accuracy
Developing Others: Places value in helping colleagues to growth by sharing targeted, actionable feedback and new insights on a regular basis.
Possess/Establishes Respect & Peer Credibility
Matrixed/Collaborative & Demonstrates Global Approach
Global Public Health
We only accept electronic applications. Interested candidates who meet the above requirements are requested to send their update resume (with photograph) and cover letter through e-mail. Please mention the position name clearly to the subject line of the mail.
All applications will be reviewed but only the short-listed candidates will be notified.
USP is proud to be an equal opportunity/affirmative action employer. Employment selection and related decisions are made without regard to sex, gender identity, race, age, disability, religion, national origin, color, veteran status or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.