Associate Process Engineer/Scientist- Drug Product, Biologics Manufacturing Science and Technology
Key responsibilities include
• Execution of post-market process change activities/experiments through partnership with R&D development assets
• Responsible for characterizing, optimizing and troubleshooting product and manufacturing processes of parenteral dosage forms.
• Work with R&D and manufacturing sites to design and execute experiments to support product robustness, new technology implementation, and/or manufacturing investigations
• Serve as technical resource to other functions, providing expertise on the product and its process.
• Effectively represent biologics drug product manufacturing science and technology in various internal and external teams and committees on development, technology transfer, manufacturing, specifications, process validations and launch.
• Provide assistance to sites globally to resolve significant quality events and manage complex change controls.
• Bachelor’s degree in relevant science or engineering discipline (chemistry, pharmaceutical sciences, pharmacy, biology, chemical engineering).
• Master or advanced degree preferred.
• Minimum of 3-5 years of experience in the Pharmaceutical or Biotechnology industry in product and process development and commercialization in a global environment.
Key Skills and Experience
• Hands-on experience in the laboratory and in-depth understanding in sterile and liquid products, particularly biologics, formulation development, analytical methods, commercial manufacturing, and their unit operations.
• In-depth understanding of Quality by Design (QbD), Design of Experiments (DOE), multivariate analysis, PAT, critical process and material attributes and CQA's.
• Working competency of Statistical Process Control and related tools (JMP/MiniTab/SAS).
• Able to design and execute scientifically sound, hypothesis driven experiments
• Skilled in writing and reviewing complex study plans and scientific reports.
• Possess high level of familiarity with sterile product processing equipment and manufacturing facilities.
• Overall knowledge of parenteral technology: aseptic processing, sterilization, isolator processing, lyophilization, pre-filled syringe operations, etc.
• Strong understanding of project management systems and tools
• Six Sigma Green/Black Belt certification desirable
Interested candidates may contact at "Praveen.arora(@)artechinfo.com or 973-507-7593