Sr. Engineer Drug Process Development

gy 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 senior 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).

• 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.

• Experience in lyophilization process development or tech transfer of lyophilization process to commercial scale.

.