Work as part of an interdisciplinary team to assist BARDA contractors to develop valid, high - yielding and economical processes and analytical methods for the production of biopharmaceutical products.
Works closely with the analytical development team and reviews analytical method, protocols, stability protocols and data, supports the API CMC development strategy for the small molecule development projects.
Design and provide day-to-day operational oversight and support to drug safety and pharmacovigilance system, ensure compliance with national, regional, and global drug safety and risk management regulations and codes of conduct.
Work towards the strategic development of the HIL as a GCLP reference laboratory for HIV prevention research and other infectious diseases, prepare and review clinical data and scientific reports and manuscripts.
Consult, provide technical expertise and thought partnership, to maximize the impact of projects and the creation of well - integrated vaccine clinical development plans, clinical study designs, statistical analysis plans, and clinical assays for vaccine clinical studies.
Support the configuration, administration and maintenance activities of the sites manufacturing computer and automation systems, including process control systems, building automation systems, manufacturing execution systems, and data historians.