The Senior Associate in Process Development at Amgen is instrumental in designing, developing, and optimizing manufacturing processes.
They are involved in conducting experiments, analyzing results, and implementing process improvements to enhance efficiency and product quality.
Process Development Responsibilities
Contributes to new product introductions and lifecycle changes to 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 contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process, and also contribute to responses 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.
Interface with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
Assist in the development and characterisation of drug product processes and transfer technology to commercial drug product sites.
Identify and implement operational opportunities for current and new sterile operations.
Troubleshoot issues with drug product processing technologies and equipment.
Conduct risk assessment for drug product operations and propose/implement appropriate CAPA.
Provide recommendations to management during investigations.
Provide support to the PD forensic lab and be a link to manufacturing on key investigations as a process expert.
Develop validation plans, process performance qualifications (PPQs) for vial and syringe filling.
Ensure all aspects of activity within any given process validation adhere 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 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 with the necessary regulations.
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 that would impact the validated process.
Assist in deviation and exception resolution and root cause analysis.
Participate as required in project activities and be developing associated project skills.
Support Process Development activities on the manufacturing line such as Engineering runs and PPQs that involve periods of shift support.
Basic Qualifications
A third-level Bachelor's degree in Science, Engineering or a relevant Quality discipline with 2-3 years' experience in a similar role OR Master's degree & 2 years of directly related experience OR Associate's degree & 5 years of directly related experience.
Knowledge of cGMPs and other worldwide regulatory requirements.
Problem-solving ability and excellent oral & written communication skills.
Preferred Qualifications
PhD or Masters in Science or Engineering.
2-3 years of experience in support of Commercial Protein Drug Product Processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes.
Knowledge of protein biochemistry regarding chemical and physical stability.
Knowledge of Quality systems, Drug Product Manufacturing and Validation.
Demonstrated ability working cross-functional teams to advance complex projects to completion.
Excellent communication skill is essential for this role.
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