Job Title: Senior Deviation Investigator – Gene Therapy Manufacturing
Location: Harmans, MD
Duration: Long Term Contract
The Position:
This position will report to the Senior Manager of Commercial MS&T and will be responsible for technical support for commercial gene therapy programs at our CDMO partners. This individual contributor will be part of team focused on review and management of major and critical deviations.
Primary Responsibilities Include:
· Lead technical discussions required to investigate deviations in a GMP environment
· Responsible for ensuring root cause analyses supporting investigations are technically appropriate
· Attend applicable meetings internally and with CDMO to provide updates on deviations.
· Review deviation and associated technical reports and ensure investigation reports are technically justified.
· Participate in major and critical deviation root cause analysis on site.
· Coach CDMO and client staff, as applicable, on deviation management.
· Assist with generation of templates and other tools to assist CDMO authors.
Education and Skills Requirements:
· Degree in Engineering or Life Sciences, with 5- 10 years of biopharmaceutical industry experience.
· Experience leading GMP investigations, including authoring, root cause analysis and CAPA development.
· Experience with Gene therapy or Biologics process in a manufacturing, quality or process development role.
· Knowledge of GMP regulations, systems for performance measure (metrics) and tools/ methodologies to drive operational excellence.
· Strong project/ program management and risk management skills.
· Experience with CDMO management preferred
· Excellent communication skills and ability to influence across multiple functions.
· 25% travel anticipated
