The U.S. Pharmacopeial Convention is looking for a consultant to collaborate with EDCL

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization.

Vacancy: Not specified

Vacancy Type: Contractual

Role: Consultant

Job Responsibilities:

• The consultant will collaborate with EDCL to provide technical expertise in the development of the vaccine manufacturing project. The objectives include reviewing the Development Project Proposal (DPP), addressing observations from the Ministry of Planning and ADB during the approval and implementation process, and facilitating understanding of the WHO prequalification application process and its linkage with DGDA's WHO GBT ML3 for vaccines. The specific tasks are-
• Collaborate with the EDCL vaccine project team (Dhaka) in reviewing the Development Project Proposal (DPP), addressing technical aspects, and ensuring alignment with GMP standards.
• Provide technical inputs to address observations from the Ministry of Planning and ADB during the approval and implementation of the project.
• Work with EDCL to identify specific technical areas requiring long-term support for successful project implementation.
• Conduct consultative meetings with EDCL management and the vaccine project team to explain the WHO prequalification application process, timeframe, and its linkages with DGDA's WHO GBT ML3.
• Assist in understanding domestic and export market requirements for vaccine products.
• Visit the vaccine manufacturing site from time to time with the EDCL vaccine project team.
• Work in collaboration with PQM+ project management and activity lead.
• Deliverables:
• Progress report on the technical support provided to review the Development Project Proposal (DPP) and

Requirements:

• In pharmaceutical sciences/regulatory affairs/ development and management studies or related fields, vaccine science will be an asset.

Additional Requirements:

• Proven experience in managing pharmaceutical projects, especially in vaccine manufacturing.
• Regulatory Affairs: Expertise in navigating regulatory requirements, particularly about WHO prequalification and FDA approval.
• Technical Expertise: In-depth knowledge of vaccine manufacturing processes, GMP standards, and pharmaceutical sector strategy.
• Project Approval Process: Experience in developing policy and strategic plans for GoB, addressing observations, and facilitating the approval process with government bodies and international funding agencies.
• Good understanding of public health systems.
• Consultation and Communication: Strong facilitation skills to conduct consultative meetings and effectively communicate complex technical information.
• Documentation and presentation skills
• Proof of implementing effective, timely, and quality implementation of donor-funded (particularly USAID-funded) global health or international development projects
• Experience in implementing technical assistance programs in expanding access to global health products and pharmaceuticals.
• Good understanding of and experience working with USAID compliance rules and regulations.
• Significant experience working with high-level officials in USAID and country governments.
• Excellent client relationship management skills.
• Excellent written and verbal communication skills.
• Ability to work in cross-cultural settings.
• Ability to demonstrate the highest degree of ethics and integrity.
• Willingness to travel.

Job Location: Dhaka.

Salary: Not specified.

Benefits: As per the Company policy.

Application Deadline: 06 January 2023

Application procedure:

Send your CV to: GPHBangladeshRecruitment@usp.org