This role will require the candidate to provide process development support to new product introductions (NPI), technology transfer, lifecycle changes to syringe products, provide subject matter expertise for product formulation, filling and characterisation to support ADL1X (SF01, SF02 and SF03) production. The candidate will provide technical support to large molecule and small molecule drug product manufacturing at ADL as well as part of the global Process Development (PD) organization. The input provided will also include support of process performance and implementation of process improvement strategies and will include the following:

• Leads new product introductions and lifecycle changes into SF01, SF02 and SF03 from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer.
• 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 syringes/devices, 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 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:

• A third level Bachelor’s degree in Science, Engineering or a relevant Quality discipline with 5 years’ experience in a similar role OR Master’s degree & 3 years of directly related experience OR Associate’s degree & 10 years of directly related experience
• Knowledge of cGMPs and other worldwide regulatory requirements.
• Problem solving ability and excellent oral and written communications skills

Preferred Qualifications:

• PhD or Masters in Science or Engineering
• 5 + years of experience in support of Commercial Protein Drug Product (DP) 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

• Project management skills including the ability to manage multiple projects and evaluate project resource requirements.

• Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skills are essential for this role.

Amgen is an equal opportunities employer.

• Leads new product introductions and lifecycle changes into SF01, SF02 and SF03 from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer.
• 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 syringes/devices, 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 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