This position is responsible for authoring, reviewing, and approving deviations and non-conformances within a biologics manufacturing setting. Strong experience in upstream processes and/or cell/gene therapy.
Key Responsibilities:
Deviation and Investigation Writing: Draft 5-7 minor deviations per week with 5-6 approved, or 3-5 major deviations weekly.
Unit Operations Expertise: Including cell culture, bioreactors, TFF, chromatography, and filtrations.
Single-Use Disposable Systems: Experience with these systems.
Root Cause Analysis (RCA): Familiarity with 5 Whys, 6Ms, and fishbone diagrams.
TrackWise System: Experience with TrackWise or similar systems.
Must-Have Qualifications:
Upstream and/or Cell/Gene Therapy Experience
Proven Experience in Authoring Deviations/Investigations
Strong Biologics Experience
Familiarity with cGMP Manufacturing Environments
Strong Writing Skills
Life Science or Engineering Degree with at least 5 years of relevant experience