Noel Long
Senior Sterility Assurance Adviser at Cytiva
- Role
- Senior Sterility Assurance Adviser at Cytiva
- Location
- Warwick, RI, US
- LinkedIn followers
- 500 followers
About Noel Long
Contamination Control and Sterility Assurance Professional playing the infinite game with in-depth understanding of global regulatory requirements across pharmaceutical, biopharmaceutical, medical device and healthcare industries with a special interest in aseptic manufacturing. Cancer survivor and family member who appreciates the legacy and future folks who contribute to cures, healing, support and relief.Subject matter expert with practical and technical experience focused on aseptic drug product manufacturing and contamination control with experience in API, cell banking, cell culture, and purification as well. Started with a Microbiology degree which led to roles in environmental monitoring, validation of sterilization processes, manufacturing (compounding, component prep, filtration, filling, lyophilization, and visual inspection), pilot plant and CDMO oversight, and quality/regulatory roles. My strength is understanding the details and seeing the big picture while constantly learning and growing through collaboration with others. Recent projects at Cytiva include the airflow visualization studies and biofluorescent particle counter studies for a gloveless robotic aseptic filling isolator. Co-chaired the PDA/ANSI Standard 03-2025, Standard Practice for Quality Risk Management of Aseptic Processes and am a new member of the PDA Journal editorial board.
Experience
Senior Sterility Assurance Adviser
Apr 2020 — Present · Marlborough, MA, US
Education
Penn State University
Microbiology
Pennsylvania State University
B.S, Microbiology
1987
Skills
- Standard Operating Procedure (Sop)
- Verification and Validation (V&V)
- Change Control
- Good Laboratory Practice (Glp)
- Microbiology
- Clinical Trials
- Biopharmaceuticals
- Cleaning Validation
- Quality Assurance
- Validation
- V&V
- Biotechnology
- Verification and Validation (V
- Pharmaceutics
- Pharmaceutical Industry
- Sop
- Glp
- Vaccines
- Technology Transfer
- Aseptic Processing
- Sterilization
- Purification
- Aseptic Technique
- Gmp
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