Process Expert (Wed-Sat, 2nd Shift)
About the Role
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing and Quality Assurance professionals to help us reach our ambitious goals.
As a Process Expert you will provide front line support to manufacturing, working with the production teams to ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. You will act as our Subject Matter Expert (SME) for product and process knowledge and will be the first point of contact for product and process related issues. Drives investigations to true root cause, and implementation of corrective and preventive actions.
• Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed.
• Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records and white papers.
• Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance and implementation of CAPAs.
• Authoring/Owning/Ensuring investigations related to material transfer, API synthesis, Drug Substance formulation, Drug product filling, inspection, and packaging.
• Ensure processes are inspection ready at all times.
• Support process optimization and new technology introduction for continued productivity improvement, as appropriate.
• Review validation protocols and reports. Support the execution of process validations, and short-term improvement projects.
• Provide guidance and support to production team through training and knowledge sharing.
• This role is Wednesday-Saturday 2nd shift (1pm-11:30pm) located on-site at our Millburn, NJ location.