Position Objective: Provide services as a Scientific Program Manager in support of the overall functions of the Division of AIDS (DAIDS), Vaccine Translational Research Branch (VRTB), Vaccine Research Program (VRP) within the National Institute of Allergy and Infectious Diseases (NIAID). Duties and Responsibilities:
Work with federal staff responsible for cGMP product development of vaccines for infectious diseases including the production of investigational products that are identified as strong candidates to move from a preclinical to clinical phase.
Plan, organize, and coordinate cGMP activities across all project stakeholders. Set deadlines, record responsibilities, and monitor and summarize progress of various cGMP manufacturing projects.
Participate as a team member in a group composed of different staffing areas including scientific/technical roles, project management, regulatory affairs, quality assurance, contracts, and finance. Activities include participating in both the development of vaccines and adjuvants, assisting in the authoring the Chemistry, Manufacturing and Controls and Toxicology sections of Investigational New Drug submissions, providing protocol and Investigator Brochure review, and assisting in providing oversight of Contract Manufacturing Organizations
Coordinate with Quality, Regulatory, and Technical team members for health regulatory compliance.
Assist the team with impact/risk assessment from issues, failures and deviations during manufacturing and pre-clinical studies.
Develop, coordinate, and monitor business agreements to include MTAs, CRADAs, DTAs, and other agreements as necessary.
Prepare technical reports, updates, and summaries for internal meetings with Division Management.
Map out VTRB process and support the development of Standard Operating Procedures (SOPs) and advise the VTRB Branch Chief if the processes are appropriate to adhere to the cGMP requirements. Stay current on training and understanding approved SOPs. Assist in tracking and periodic review of VTRB SOPs.
Maintain an organized, efficient, and accessible electronic document filing system. This includes historical, current, and projected information on proposals, presentations, business agreements, grant awards, cGMP projects, and other Branch activities.
Review, GMP manufacturing batch records, SOPS, deviation reports, etc.
Participate with Team members to track product stability reports with respect to stability timepoints, review the product stability protocol for consistency and completeness, ensure that the stability program matches the requirement per the project Statement of Work, review stability Certificate of Analysis and/or Stability reports/data for out of specification testing results, issue the Shelf Life Extension document after reviewing of the stability report.
Assist in the preparation and review of regulatory documents including pre-IND materials, and IND, as required.
Prepare oral and written presentations for internal and external programmatic and scientific meetings.
Basic Qualifications:
M.S. degree in biochemistry or biology or equivalent education and at least 8 years of experience in industry, or B.S. degree in biochemistry or biology or equivalent education and at least 10 years of experience in industry
Minimum Qualifications:
PMP certification and experience in managing cGMP of biologics 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.
Requisition ID: 6711
Full-time