Senior Technical Officer, Vaccine Product Development Partnership
*Please note this position is contingent on obtaining funding.
PATH is an international nonprofit organization that transforms global health through innovation. PATH takes an entrepreneurial approach to developing and delivering high-impact, low-cost solutions, from lifesaving vaccines and devices to collaborative programs with communities. Through our work in more than 70 countries, PATH and our partners empower people to achieve their full potential.
PATH’s Vaccine Development Global Program (VAC) is working to accelerate the development of new vaccines targeted against rotavirus, influenza, respiratory syncytial virus (RSV), pneumococcus, ETEC, Shigella, polio and meningococcus. The goal is to develop new safe, effective, affordable vaccines which are appropriate for use in the developing countries that most urgently need them.
The Vaccine Product Development Partnership (VPDP) Technical Support project’s purpose is to audit and assess Chemistry, Manufacturing, and Controls (CMC) service providers used by global health product development partnerships (PDPs) of the Bill and Melinda Gates Foundation. This position will act as a liaison between the CMC service provider, PDP, and auditing firm. The Technical Officer will accompany the auditor during their audit, review the report for completeness and accuracy, brief the PDP on observations during the audit, and provide the report to the PDP and the Foundation. Specific responsibilities include:
- Provide technical leadership for the VPDP audit program administered by PATH.
- Serve as liaison between partners, donors, and audited sites.
- Critically interpret scientific data and conclusions from vaccine development projects and assist in decision making on continuation of the projects.
- Analyze risks, opportunities and challenges, seek solutions and supervise project implementation to ensure achievement of targeted milestones.
- Provide strategic and technical guidance to VAC’s Senior Technical Advisor.
- Evaluate industrial processes for robustness, cost efficiency, and compliance with GMP, quality, and health/safety/environmental requirements.
- Review plans against Quality Assurance and Quality Control requirements including WHO Prequalification standards
- Conduct technical (process development/manufacturing/quality assurance) due diligence of potential partners.
- Provide technical review of pharmaceutical plans and technical documentation relative to vaccine manufacturing facilities.
- Experience assessing process development, manufacturing and quality assurance in biotechnology and/or large pharmaceutical companies.
- Experience in GMP manufacture of biological products for clinical trials and for commercial use.
- Experience in applying US and international regulations and WHO prequalification standards to the manufacture and release of biological products for human use.
- Experience in evaluating/conducting due diligence of manufacturing facilities.
- Proven ability to manage areas of specialization by identifying and managing external consultants where needed.
- Experience in technical report writing.
- Experience with developing-country vaccine manufacturers a plus.
- Fluency in English; excellent written and oral communication skills.
- Ability to travel internationally and domestically up to 50 percent.
Relevant Master's degree plus minimum seven years' relevant experience in scientific discipline or related field planning, conducting, managing or overseeing GMP/GLP audits, Process Development and cGMP manufacturer of clinical material. Experience with pharmaceutical quality operations is critical for the job as is auditing experience; knowledge of vaccine manufacturing a plus.
PATH is dedicated to diversity and is an equal opportunity employer.
Must have legal authorization to work in the United States.
Post a Comment