Amgen
Biotechnology
Sr.AssociateProcessDevelopment
Neural analysis suggests this role is
optimal for Associate candidates.
“Sr. Associate Process Development at Amgen. Skills: Process Development, Drug Product Manufacturing, Sterile Processing, Process Characterization, Tech Transfer, Validation, cGMP, Regulatory Requirements. Designing, developing, and optimizing manufacturing processes. Conducting experiments, analyzing results, and implementing process improvements”
What You'll Achieve.
enhance efficiency and product quality; advance complex projects to completion; ensure continued compliance to the necessary regulations
Industry & Context.
Problem solving ability; Provide solutions when troubleshooting; Technical evaluation of NC/CAPA; Troubleshoots issues with drug product processing technologies and equipment; Conducts risk assessment; Assist in deviation and exception resolution and root cause analysis
periods of shift support
What They're Looking For.
Must Have
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
Nice to Have
PhD or Masters in Science or Engineering, 2-3 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, 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
What You'll Do.
and optimizing manufacturing processes
Conducting experiments
and implementing process improvements
Provide process development support to new product introductions (NPI) and lifecycle changes
Contribute to subject matter expertise for unit operations and support ongoing production
Provide technical support to large molecule and small molecule drug product manufacturing
Support of process performance and implementation of process improvement strategies
Contributes to new product introductions and lifecycle changes to PM2 and PM3 from a Process Development perspective
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
Contribute to responses to regulator questions
Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing
filling vials/syringes/devices
and transportation for parenteral products
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
Assists in the development and characterisation of 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
Conducts risk assessment for drug product operations and proposes / implements appropriate CAPA
Provides 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
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 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
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
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 involves periods of shift support
How You'll Work.
Team & Collaboration
Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing; Participate in validation cross functional teams at the site; Liaise with Operations, Engineering and external vendors; Demonstrated ability working cross-functional teams to advance complex projects to completion
Communication Scope
Excellent oral & written communications skills; Excellent Communication skill
Process & Methodology
Project activities
Full Job Description
## **Career Category** Scientific ## ## **Job Description** 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. This role will require the candidate to provide process development support to new product introductions (NPI) and lifecycle changes to site, contribute to subject matter expertise for unit operations and support ongoing 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 organization. The input provided will also include support of process performance and implementation of process improvement strategies and will include the following: * 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 but 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. Interfaces with manufacturing as well as all support functions to provi
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