Sr. Engineer Drug Process Development
2 weeks ago
Sr. Engineer Drug Process Development page is loaded Sr. Engineer Drug Process Development Apply remote type Flex Commuter / Hybrid locations Ireland - Dun Laoghaire time type Full time posted on Posted 3 Days Ago job requisition id R-187386 Career Category Process Development Job Description
Job Posting Title Sr Engineer - Drug Process Development
Career Category Process Development
Employee Subgroup TBC
Country (State/Region) Ireland
Location (City) Ireland - ADL
Amgen Job Description
The Sr Engineer provides process development 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 include support of process performance and implementation of process improvement strategies:
• Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug product lyophilization as well as formulation, filtration and filling vials/syringes/devices for parenteral products.
• Develops and characterizes drug product lyophilization processes and transfer technology to commercial drug product sites.
• Provides 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.
• Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine true root cause.
• Conducts risk assessment for drug product operations and propose / implement appropriate CAPA.
• Identifies and implements operational opportunities for current and new sterile operations.
• Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.
Basic Qualifications
• Bachelors degree & 8 years of directly related experience OR
• Masters degree & 6 years of directly related experience OR
• Knowledge of aseptic manufacturing technologies and cGMPs
Preferred Qualifications
• Masters / PhD in a related Science or Engineering discipline
• 10+ years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Process Characterization or Tech Transfer (to commercial DP sites).
• Experience in lyophilization process development or tech transfer of lyophilization process to commercial scale.
• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry with regard to 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, as well as a demonstrated proficiency with the principles of Technical Writing.
. Similar Jobs (1) Sr. Engineer - System Owner - 12 month FTC remote type On Site locations Ireland - Dun Laoghaire time type Full time posted on Posted TodayAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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