We currently have two roles open with our client - remote working with between 25% and 50% travel throughout Europe.
Both roles are within Fill Finish - one position, candidates must have previous experience with Pre Filled Syringes.
Ex M Tech Ops is accountable for technology transfers and commercial production of sterile drug product at our External Partners (EPs).
This may include supporting the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and to provide support for process and capacity optimization.
Responsibilities Work with External Partners to achieve business goals and to establish a common culture that benefits our company, External Partners, and patients.
Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners.
Ensure that External Partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.
Minimum of 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance.