Responsible for executing technology transfer activities for injectable dosage forms, including planning and performing Scale-up, Exhibit and Process Validation batches with optimal utilization of manpower, materials, and equipment.
Handling and maintaining of fully auto mated Glatt integrated line (Horizontal)/Octagonal Blender / Bin Blender / Sifter / Mill Fette Compression machine / Capsule filling machine with line equipment / Automated Tablet and Capsule visual
Expertise in evaluating and on boarding CRO / CMO vendors, managing technical, commercial, and compliance aspects, ensuring alignment with regulatory, quality and project timelines.
Advanced degree in life sciences / pharmacy / similar discipline or medical degree. Stakeholder management; writing/communication skills; external engagement and ability to work independently and within a team environment
Must have Expertise in OSD / Sterile / Liquid. Handling of change controls related to Master Production / Packaging / Validation documentation via QMS Track Wise.
AVP will lead Amgen’s Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs.