Sterility Technical Services

A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Container Closure Validation, Leaks and Glove Management, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs.
The scope of the role includes syringe filling and device assembly &
packaging operations for commercially manufactured products targeted for transfer to the RTP site.
Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.G., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)
Assists with writing of regulatory submissions for sterility assurance programs.
Create, review, approve and provide sterility assurance training for new hires and personnel from other sites.
Provide technical mentorship to a less senior scientists within the TS/MS organization.
Provide technical mentorship to a less senior cross-functional personnel within RTP.
The Sterility Assurance Steward implements 3 primary objectives:
(1) reliable, compliant manufacturing of the drug product.
(2) improvement of the process control strategy, continuous optimization, development of technologies.
(3) continual deepening of the scientific understanding of sterility assurance. The technical agenda exists throughout the entire product, process, and facility lifecycle.
Requirements
BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
10 years’ experience in the biopharmaceutical industry