Job Description:
* We are seeking a talented Manufacturing Process Specialist to provide support for new product introductions and lifecycle management changes.
* The ideal candidate will have expertise in technical evaluation of change control, NC/CAPA, and technology transfer to support commercial drug product manufacturing operations.
Main Responsibilities:
* This role is accountable for the success of product transfer projects from initiation to transfer, including line characterization, engineering studies, process performance qualification, and regulatory approval.
* The successful candidate will provide solutions when troubleshooting issues related to drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation for parenteral products throughout the NPI or post-NPI phases.
* This position will develop validation plans, process performance qualifications for vial and syringe filling, and ensure adherence to required policies and procedures, including safety and training.
* As a key member of cross-functional teams, this individual will participate in process validation and be responsible for delivering against organizational goals and project milestones.
Requirements:
* A third-level Bachelor's degree in science, engineering, or a relevant quality discipline, with at least 5 years' experience in a similar role.
* Detailed knowledge of cGMPs and other worldwide regulatory requirements.
* Excellent problem-solving ability and communication skills, both oral and written.