Leads new product introductions and lifecycle changes into PM2 and PM3 from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer to PM2 or PM3.
Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also be responsible for response to regulator questions as and when required.
Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation for parenteral products through the NPI or post-NPI phases.
Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
Develops and characterizes drug product processes and transfers technology to commercial drug product sites.
Identifies and implements operational opportunities for current and new sterile operations.
Troubleshoots issues with drug product processing technologies and equipment.
Leads and conducts risk assessment for drug product operations and propose / implement appropriate CAPA.
Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management. Provide support to the PD forensic lab and be a link to manufacturing on key investigations as a process expert.
Development of validation plans, process performance qualifications (PPQs) for vial and syringe filling.
Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards).
Participate and lead in validation cross functional teams at the site to ensure adherence to required policies and procedures.
Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations.
Input to site validation guidance documents.
Collate and report on relevant shipping and filter validation.
Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
Contribute to product quality assessments and process flow documents.
Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated process.
Lead or assist in deviation and exception resolution and root cause analysis.
Participate as required in project activities and be developing own project management techniques.
Basic Qualifications:
Preferred Qualifications:
Amgen is an equal opportunities employer.
Join Us
If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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