Biologics Manufacturing Specialist

3 weeks ago


Harmans, Maryland, United States LanceSoft, Inc. Full time
Job Title: Quality Assurance Specialist

This role is responsible for ensuring the quality and integrity of biologics manufacturing processes. The ideal candidate will have strong experience in upstream processes and/or cell/gene therapy.

Key Responsibilities:
  • Deviation and Investigation Writing: Draft and approve deviations and investigations with a focus on root cause analysis and corrective actions.
  • Unit Operations Expertise: Develop and maintain expertise in cell culture, bioreactors, TFF, chromatography, and filtration systems.
  • Single-Use Disposable Systems: Collaborate with cross-functional teams to implement and maintain single-use disposable systems.
  • Root Cause Analysis (RCA): Apply analytical skills to identify and resolve complex issues using tools like 5 Whys, 6Ms, and fishbone diagrams.
  • TrackWise System: Utilize TrackWise or similar systems to manage and track deviations, investigations, and corrective actions.
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


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