Consultant - Technical Assistance

Job Description

Title: Consultant - Technical Assistance

Company Name: United States Pharmacopeial Convention (USP)

Vacancy: --

Location: Anywhere in Bangladesh

Salary: Negotiable

Published: 5 Nov 2024

Additional Requirements:
∎ USP is looking for an individual consultant to complete the assignment. The consultant should bring the following qualifications and experiences:
∎ Educational background: Pharmaceutical sciences/Biological science/ regulatory affairs/ development and management studies or related field, vaccine science will be an asset.
∎ Pharmaceutical Project Management: Proven experience in managing pharmaceutical projects, especially in vaccine manufacturing.
∎ Regulatory Affairs: Expertise in navigating regulatory requirements, particularly in relation to 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 skill
∎ The consultant will work with EDCL and ADB or MOHFW-assigned personnel (as applicable). S/he will also work at the USP office.
∎ Skills and Experience required:
∎ Work station/Service Delivery place:
∎ Period of Performance: From the time of initiation till May 25th, 2025. Maximum allowable 15 days/month
∎ Legal documents: Valid Business Identification Number (BIN) and Proof of Submission Return (PSR)
∎ Payment Terms: Payment will be made in the next 30 days after submission of invoice and monthly progress report/assigned deliverables confirmation. VAT will be added and TAX will be deducted as per the government policy.

Requirements:

Responsibilities & Context:
∎ The consultant will collaborate with EDCL to provide technical assistance in building their capacity on the technical areas identified in the previous program year. The specific tasks are-
∎ Coordinate with PQM+ subject matter expert in developing the training materials for the training on commissioning, qualification, and validation of vaccine manufacturing
∎ Provide support and act as a co-facilitator for the training on commissioning, qualification, and validation of vaccine manufacturing.
∎ Coordinate with the PQM+ subject matter expert in preparing the training report
∎ Work with EDCL to provide on-the-job training in the identified technical areas of vaccine project implementation.
∎ Provide technical inputs to EDCL to address observations from the Ministry of Planning and ADB as applicable during vaccine project implementation.
∎ Visit the vaccine manufacturing site with the EDCL vaccine project team as needed.
∎ Work in collaboration with PQM+ project management and activity lead.
∎ Any other tasks assigned by the PQM+ management.
∎ Training report on commissioning, qualification, and validation of vaccine manufacturing
∎ Monthly progress report on the technical assistance provided and on-the-job training conducted.
∎ Objectives of the assignment:
∎ The Government of Bangladesh, through the Asian Development Bank (ADB) funding project ‘’Vaccines, Therapeutics, and Diagnostics Manufacturing and Regulatory Strengthening (VTDm-RS) under the Asia-Pacific Vaccine Access Facility (APVAX) has tasked the state-owned enterprise Essential Drugs Company Limited (EDCL) with developing a Biotech Research Center and a Biotech manufacturing plant in Gopalganj district.
∎ In the previous program year (PY5), PQM+ provided TA to EDCL’s vaccine project team to complete and review the draft project proposal for vaccine manufacturing through ADB funding. PQM+ organized several consultative meetings with the EDCL vaccine project team and identified the technical areas where the team members need understanding and capacity building to support the vaccine project implementation. The identified TA are commissioning, qualification, and validation on vaccine manufacturing, design review, design implementation activity review, development of biopharmaceuticals QMS, technology transfer assistance, process optimization and validation, pre-clinical and clinical trials design (Phase I, Phase II, Phase III), and advisory services for regulatory requirements of USFDA and WHO for biopharmaceuticals.
∎ In the current program year, PQM+ will assist the EDCL in organizing training on the commissioning, qualification, and validation of vaccine manufacturing for its vaccine project team. PQM+ will select, customize, and organize training materials based on the USFDA and WHO guidelines. In addition, PQM+ will continue to provide TA to the EDCL’s vaccine project team to build capacity through on-the-job training in the areas identified in the previous program year.
∎ Specific Tasks
∎ The consultant will collaborate with EDCL to provide technical assistance in building their capacity on the technical areas identified in the previous program year. The specific tasks are-
∎ Coordinate with PQM+ subject matter expert in developing the training materials for the training on commissioning, qualification, and validation of vaccine manufacturing
∎ Provide support and act as a co-facilitator for the training on commissioning, qualification, and validation of vaccine manufacturing.
∎ Coordinate with the PQM+ subject matter expert in preparing the training report
∎ Work with EDCL to provide on-the-job training in the identified technical areas of vaccine project implementation.
∎ Provide technical inputs to EDCL to address observations from the Ministry of Planning and ADB as applicable during vaccine project implementation.
∎ Visit the vaccine manufacturing site with the EDCL vaccine project team as needed.
∎ Work in collaboration with PQM+ project management and activity lead.
∎ Any other tasks assigned by the PQM+ management.
∎ Deliverables:
∎ Training report on commissioning, qualification, and validation of vaccine manufacturing
∎ Monthly progress report on the technical assistance provided and on-the-job training conducted.

Employment Status: Full Time

Job Location: Anywhere in Bangladesh

Read Before Apply:

An updated CV with cover letter, and at least three (3) references

Expected daily rate to deliver the scope of work (SOW) excluding travel cost. The travel cost will be reimbursed by PQM+.

We only accept the electronic application.