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 matterexpertisefor 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.
Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, fillingvials/syringes/devices,lyophilization, inspection, and transportation for parenteral products through the NPI or post-NPI phases.
Provide process developmentexpertisefor commercial drug product processing in specific areas such as sterile processing, process characterization, techtransferand 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.
• A third levelBachelor’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 ofdirectly relatedexperience ORAssociate’sdegree & 5 years ofdirectly relatedexperience
• Knowledge ofcGMPsand other worldwide regulatory requirements.
• Problem solving ability and excellent oral & written communications skills.
Preferred Qualifications:
• PhD orMasters 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.
• 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 biochemistryregardingchemical 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.