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.
This role includes supporting process performance and implementation of process improvement strategies:
Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices and lyophilization for parenteral products.
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.
Leads and participates in global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.
Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine true root cause.
Develops and characterizes drug product processes and transfer technology to commercial drug product sites.
Authors and reviews guideline documents, technical protocols, reports, product impact assessments and regulatory submissions.
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 or Masters degree in Engineering or Science with 6 years of experience in a similar role OR PhD and 4 years directly related experience.
Knowledge of aseptic manufacturing technologies and cGMPs
Preferred Qualifications
Masters / PhD in a related Science or Engineering discipline
Typically 6+ years of experience supporting 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 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.