The U.S. Pharmacopeial Convention (USP) Technical Advisor in Rockville, Maryland
Summary of the Position
The professional in this role will play a strategic role in expanding the competencies and capabilities in vaccines and other medical products manufacturing. Not only will the individual be responsible for providing technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of quality-assured vaccines and essential medical products, but s/he will be the key interface with internal USP departments as well as regulators and manufacturers of medical products.
Roles and Responsibilities
Lead in the provision of PQM+ technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of quality-assured vaccines and essential medical products.
Provide technical assistance to manufacturers in GLP, GMP, technology transfer, and dossier development and submission through audits, trainings, and deployment of tools and approaches to ensure adoption of international quality standards.
Provides oversight for local CMC staff, local partners and consultants involved in delivery of manufacturing support
Identify CMC risks and support the development of mitigations and contingency plans.
Conduct audits to assess compliance with international standards from WHO Technical Report Series of the Expert Committee of Biological Standardization, WHO Prequalification process for vaccines and biotherapeutic products and support manufacturers to develop strategies and tools to address deviations and non-compliance identified.
Support LMIC regulatory inspectorates to develop manuals and SOPs for inspection of vaccines and sterile manufacturing facilities.
Work closely with teams to support development and deployment of strategies in vaccine sector development
Supports the work and efforts of the Senior Technical Advisor, Product Supply Management and CMC to develop technical documents on the manufacturing of quality vaccines and other medicines
Keep abreast of the latest analytical technology in industry and regulation requirements
Technical POC at global level
Recognized leader actively advancing and deploying new technologies and trends in vaccines manufacturing
Represents USP and PQM+ Program in local and regional forums on manufacturing
Actively contribute to annual programmatic and resource planning process and contribute to programmatic growth.
Five years experience in vaccines and biologics manufacturing
BS, MS or Ph.D. degree in pharmacy, pharmaceutical science, chemistry, engineering or science related field of study required
Subject matter expert in vaccine/biopharmaceutical manufacturing processes, comparability/feasibility studies, stability studies, analytical development, and regulatory filings
Demonstrated understanding of Chemistry, Manufacturing and Controls and Good Manufacturing Practices for medicines and vaccines e.g. fill and finish, packaging and other relevant areas
Knowledge of regulatory requirements related to the development and manufacture biologics and/or medicines in all phases of clinical development
Direct experience with regulatory authority registration processes
Strong written (especially technical writing) and oral communication skills
Willingness to travel up to 25% of the time
Direct experience implementing USAID-funded programs
Experience in at least one of the following health areas: HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH
Experience with including water systems, sterility, HVAC, contamination, analytical chemistry, cleaning procedures, validation, bioprocessing, separation, purification, formulations and other relevant areas
Experience working with a range of vaccine technologies that can include bacterial fermentation, egg-based vaccines, protein sub-units, viral vectors, and mRNA
Direct experience with and understanding of WHO vaccine pre-qualification and/or other regulatory authority registration processes
COVID- 19 Protocols
The following COVID-19 provisions will apply to selected candidate(s) hired:
As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1 st , 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Technical Programs
Job Type Full-Time