Organization: Sabin Vaccine Institute
Location: Houston, Texas
Program: Vaccine Development
Reports to: Director, Regulatory Affairs and Quality Assurance, Vaccine Development
The Program Officer, Quality Assurance, Vaccine Development will be responsible for quality assurance functions. This individual will work closely with counterparts in Washington, DC to oversee the Quality Assurance team’s mission, ensuring that vaccines developed are of high quality and all related materials, processes and personnel comply with the requirements. The incumbent will have an advisory role for non-regulated research studies that support Sabin PDP projects.
The Program Officer’s tasks will primarily be focused in pre-clinical vaccine development activities, and will include the oversight and improvement of new and existing documentation systems and databases. The individual will review, revise and create, as needed, Standard Operating Procedures (SOPs) to accommodate Sabin’s Core Quality System. This individual must demonstrate the ability to handle multiple priorities and interface with individuals from cross-functional areas of the PDP and external vendors. This individual will review and compile materials for technical transfers and CMC. The Program Officer will help in defining programmatic milestones and assessing critical resources and timelines related to quality concerns.
The Program Officer will report directly to the Director, Regulatory Affairs and Quality Assurance, Vaccine Development and work closely with all members of the Vaccine Development team and partners.
Sabin Vaccine Institute (Sabin) is a non-profit, 501(c)(3) organization of scientists, researchers and advocates dedicated to reducing needless human suffering caused by vaccine preventable and neglected tropical diseases. Sabin works with governments, leading public and private organizations, and academic institutions to provide solutions for some of the world’s most pervasive health care challenges. Since its founding in 1993 in honor of the oral polio vaccine developer, Dr. Albert B. Sabin, the Institute has been at the forefront of efforts to control, treat and eliminate vaccine preventable and neglected tropical diseases by developing new vaccines, advocating use of existing vaccines, and promoting increased access to affordable medical treatments. For more information please visit www.sabin.org.
An essential element of the Sabin Vaccine Institute’s Vaccine Development program is to reduce human suffering caused by infectious and neglected tropical diseases (NTDs) through the development and testing of new and novel vaccines. The Sabin Vaccine Development program is pioneering the development of vaccines, which have no traditional commercial market. The diseases we combat represent the most common scourges of the world’s poorest people.
In 2000, Sabin established an innovative non-profit Product Development Partnership (PDP) to develop new vaccines for human hookworm infection and other NTDs, including schistosomiasis. Our Human Hookworm Vaccine Initiative (HHVI) is the first and only initiative with a mission to develop a vaccine to confer preventive immunity against human hookworm infection (‘hookworm’), an NTD that threatens vulnerable populations around the globe. Our innovative Vaccine Development program has established a vaccine development pipeline that contains multiple antigens at various stages of development. Currently, our vaccines are undergoing clinical testing in Brazil.
Essential Duties and Responsibilities:
- Manage raw material release and qualifications for all laboratories
- Ensure that equipment is maintained according to requirements
- Develop, write, update and revise SOPs as necessary
- Support laboratory personnel through the implementation of training workshops on subjects such as cGMP and GLP
- Review and approve laboratory, animal and batch production records for the performance of formal testing at external facilities and the development labs at Baylor College of Medicine and the George Washington University
- Conduct data, systems and in-process audits
- Assist in development and maintenance of document archives
- Track release and stability testing of regulated products
- Monitor system for vendor audits to initiate audits once period established has expired
- Conduct and assist with document, facility and procedural audits of contracted organizations to ensure compliance with domestic and international ethical and regulatory guidelines
- Provide support in the preparation and submission of regulatory applications with the FDA, ANVISA and other regulatory authorities, including the review and compilation of CMC and other quality documents
- Participate in cross-functional teams to develop product development strategy for current and new vaccines
- Support the Director of Quality Assurance and Regulatory, as needed
Experience and Educational Requirements:
- A Bachelor’s or Master’s Degree in a relevant scientific discipline
- A minimum of 3-5 years of experience in the pharmaceutical industry in Quality Assurance/Control, Manufacturing or Process/Analytical Development
- Knowledge of FDA requirements (as appropriate)
- Ability to perform complex statistical analysis
- Experience developing and reviewing SOPs, protocols, batch records and testing records
- Excellent written and oral communication skills
- Ability to perform detail-oriented work with a high level of accuracy
- Ability to accept supervision and work effectively in challenging situations
- Ability to critically review data to identify concerns
- Ability to travel up to 10% of the time required
How to Apply:
To be considered, please submit your cover letter, resume and salary requirements via e-mail to email@example.com, fax to 202-842-7689 or mail to HR Manager, Sabin Vaccine Institute, 2000 Pennsylvania Avenue, NW, Suite 7100, Washington, DC 20006. Please be sure to reference “VD PO QA Texas” in the subject line. Your cover letter should: (1) address the reasons for your interest in this position; and, (2) describe the knowledge, skills and abilities you would bring to the Sabin Vaccine Institute and its Vaccine Development program. No phone calls, please. Only short-listed candidates will be contacted.
Salary commensurate with qualifications and experience. Sabin Vaccine Institute has a generous benefits package.
Sabin is an Equal Opportunity Employer. All persons shall have the opportunity to be considered for employment without regard to their race, color, religion, national origin, ancestry, age, disability or handicap, sex or gender, sexual orientation, marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.