Associate Process Engineer/Scientist

Title: Associate Process Engineer/Scientist

Location: New Brunswick, NJ

Job ID: 21528-1

Duration: 6+ months with potential for extension

Job Description:

Associate Process Engineer/Scientist- Drug Product, Biologics Manufacturing Science and Technology
Description
The Process Engineer/Scientist conducts product and process characterization studies; collaborates with research and development in drug product process development of sterile parenteral and biologics drug product and works with manufacturing sites to characterize, troubleshoot or optimize processes for lifecycle products. This position is accountable for the design and execution of process characterization to ensure design and transfer of robust manufacturing processes for new products and key life cycle management products, development of new technology for optimization and continuous improvement in manufacturing operations, and providing specialized expertise as necessary to complement site capabilities for critical investigations or process improvements.
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.

Qualifications
• 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

All your information will be kept confidential according to EEO guidelines.