Technical Officer - Microbiology

Job Description

Title: Technical Officer - Microbiology

Company Name: U.S. Pharmacopeial Convention

Vacancy: Not specific

Job Location: Dhaka

Employment Status: Full-time

Educational Requirements:
∎ Bachelors/Master's degree in Microbiology or related field of study

Experience Requirements:
∎ At least 6 year(s)

Job Context:
∎ 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 Technical Officer-Microbiology will provide technical assistance to the Directorate General for Drug Administration (DGDA) network of laboratories to build their capacity to ensure the quality of medical products circulating in the Bangladesh and global market. S/he must possess a deep understanding of the pharmaceutical regulatory environment in low income and middle-income countries to provide technical oversight for strengthening the capacity of laboratories responsible for assessing the quality of medical products and vaccines. The selected candidate will engage with and leads all technical support provided to microbiology laboratory in NCL, Bangladesh. As the lead for PQM+ microbiology activities in Bangladesh, the 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 will assign as a point of contract, interfacing with DGDA, NCL and stakeholders involved in microbiology and vaccine lab support.
∎ Preferred Competency:
∎ Expertise:
∎ 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.
∎ Collaboration:
∎ 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.
∎ Initiative:
∎ 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
∎ Growth:
∎ Developing Others: Places value in helping colleagues to growth by sharing targeted, actionable feedback and new insights on a regular basis.
∎ Position Type: Full-time/Regular
∎ Job Category: Global Public Health

Job Responsibilities:
∎ Provides technical assistance to DGDA's National Control Laboratory to increase its microbiology and vaccine laboratory's capacity for testing through providing training on testing scopes and compendial methods.
∎ Provides support to the laboratories in performing proficiency testing of its testing scope, develop instrument calibration and qualification program, strengthen the laboratory's QMS through implementation of internal audit, CAPA management, and document control.
∎ Reviews/develops and implements of SOPs, guidelines.
∎ Partner with the laboratories during ISO/WHO inspections and in the development and implementation of CAPA plans.
∎ Conducts hands-on training on Gel doc system, ELISA reader, Electrophoresis unit, UV-spectrophotometer, PCR system, Autoclave, Incubator, TOC analyzer, Bio-safety Cabinet, kinetic LAL analyzer, etc.
∎ Partners with country's team in the WHO global benchmarking tool (GBT) assessment of vaccine lot release function of DGDA to achieve WHO Maturity Level-3.
∎ Develops and implements validation program in the scopes of testing.
∎ Keep abreast of the latest regulatory trends and WHO guidance
∎ Partners with country teams to develop and deploy strategies in health sector development program.
∎ Keep abreast of the latest analytical technology in vaccine and regulation requirements
∎ Actively contributes to annual programmatic and resource planning process and to the development of quarterly and annual reports

Additional Requirements:
∎ Six (6) years' experience leading and providing technical assistance to Microbiology laboratories in medicine regulatory authorities (MRAs) to ensure the availability of quality medical and vaccine products.
∎ Demonstrated direct experience implementing USAID-funded programs
∎ Skills sought: Working understanding of Chemistry, Manufacturing and Controls and Good Manufacturing Practices
∎ Preferred Qualifications:
∎ Direct experience with and understanding of WHO pre-qualification process and global benchmarking tool
∎ Experience in HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH
∎ Working knowledge and understanding of regulatory systems strengthening in Bangladesh with an emphasis on Quality Assurance/ Quality Control of medical and vaccine products
∎ Strong written (especially technical writing) and oral communication skills

Application Deadline: 8 Oct 2020

Company Information:
∎ 30 Sep 2020
∎ U.S. Pharmacopeial Convention
∎ Business : The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization founded in 1820. It 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.

Category: Medical/Pharma