Senior Scientific Program Manager

Position Objective: Provide services as a Senior Scientific Program Manager in support of the overall functions of the Vaccine Translational Research Branch, Vaccine Research Program, Division of AIDS (DAIDS) within the National Institute of Allergy and Infectious Diseases (NIAID).

Duties and Responsibilities:  

• Provide regulatory expertise and strategies for investigational biologics including early development, production and pre-clinical in vivo studies for a successful IND submission or equivalent approach for trials planned outside the US.
• Evaluate and propose appropriate toxicity studies and models for products intended to be studied as vaccines.
• Prepare Chemistry, Manufacturing and Controls (CMC) and Non-clinical study sections for regulatory submissions by acting as the scientific writer from available source documents.
• Communicate with the FDA for submissions/meeting requests.
• Coordinate with Quality and Technical team members for cGMP regulatory compliance.
• Provide regulatory advice and recommendations to the Project Lead for manufacturing projects and pre-clinical studies.
• Support the development of VTRB Standard Operating Procedures (SOPs) and advise the Branch Chief if the processes are appropriate to adhere to the cGMP requirements. Stay current on training and understanding approved SOPs.
• Assist with drafting regulatory documents and review manufacturing proposals and Quality Agreements from potential CMOs and Partners, as needed.
• Provide Subject Matter Expertise to assigned projects in viral clearance studies, formulation, processes, analytical development and manufacturing of engineering and GMP batches of biologics, adjuvants, and diluents.
• Review documents supporting developmental and manufacturing activities, including, viral clearance study protocol/reports, tox study protocols/reports, formulation/process/analytical method development reports, methods validation  protocol/reports, specifications for DS and DP, deviations, manufacturing batch records, and release of GMP materials.
• Assist the team with impact/risk assessment from issues, failures, and deviations during manufacturing and pre-clinical studies.
• Prepare technical reports, updates, and summaries for internal meetings with Division Management.

Basic Qualifications:

• Ph.D. and at least 10 years of experience is required.
• Knowledge of U.S. FDA regulations and guidelines, ICH Guidelines, International Health Regulations and their application to biologics is required.

Minimum Qualifications:

• Experience working at the U.S. FDA is preferred.
• Regulatory Affairs Certification is preferred
• Ability to communicate effectively, orally and in writing, with non-technical and technical staff.
• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.  

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

This position is contingent upon contract award.