JOB TITLE:Process Engineer/Scientist
DURATION: 06 MONTHS
Location: New Brunswick,NJ
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. Projects include formulation, sterile filtration, filling and lyophilization operations. 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.
MAJOR DUTIES AND RESPONSIBILITIES 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 (including formulation, sterile filtration, aseptic filling into vials/syringes, and lyophilization operations). Work with R&D and manufacturing sites to design and execute experiments to support product robustness, new technology implementation, and/or manufacturing investigations
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.
Bachelors degree in relevant science or engineering discipline (chemistry, pharmaceutical sciences, pharmacy, biology, chemical engineering). Master or advanced degree preferred.
Experience / Knowledge Desired:
- Minimum of 2-4 years of experience in the Pharmaceutical or Biotechnology industry in product and process development and commercialization in a global environment.
- Hands-on experience in the laboratory and in-depth understanding in sterile and liquid products, particularly biologics, formulation development, analytical methods, commercial drug product manufacturing, and their unit operations (form/fill, filtration, lyophilization).
- In-depth understanding of Quality by Design (QbD), Design of Experiments (DOE), multivariate analysis, PAT, critical process and material attributes and CQA's.
- 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