Principal Scientist, Sterile Drug Product Aseptic (manufacturing, Science & Technology)
Bristol Myers Squibb
Cruiserath, Ireland
50% onsite
Sterility oversight for aseptic filling
Contamination control strategy
Environmental monitoring trend analyses
Bristol Myers Squibb is seeking a Principal Scientist for their Sterile Drug Product Aseptic team in Cruiserath, Ireland. The role involves providing sterility oversight and leading media fill activities, ensuring compliance with regulatory standards, and requires extensive experience in sterile drug manufacturing and aseptic processes
Job Summary
The incumbent will provide sterility oversight to ensure of the aseptic filling process and Quality & Regulatory Compliance for the aseptically manufactured products, processes & systems occurs in accordance with Regulations and BMS requirements.
This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
Matching Summary
Match Score: 85
Bristol Myers Squibb is seeking a Principal Scientist for their Sterile Drug Product Aseptic team in Cruiserath, Ireland. The role involves providing sterility oversight and leading media fill activities, ensuring compliance with regulatory standards, and requires extensive experience in sterile drug manufacturing and aseptic processes.
Skills & Requirements
Must-have
Sterility oversight for aseptic filling
Contamination Control Strategy
Environmental Monitoring Trend Analyses
Aseptic Training and Qualification programs
Health Authority inspections participation
Nice-to-have
Innovative approach to regulatory trends
Proactive stakeholder collaboration
Action-oriented and embraces complexity
Key Requirements
BS in Life Sciences (Microbiology, Pharmacy, Biology, or related)
Minimum 10 years sterile drug product manufacturing experience
Minimum 5 years Media Fills / Aseptic Process Simulations experience
Extensive knowledge in Sterility Assurance, Microbiology, EM, Aseptic Manufacturing