- Provides data analysis, data management, statistical process control, and process system engineering technical expertise required to support clinical and/or commercial manufacturing.
- Provides engineering and scientific leadership in the corresponding areas.
- Defines, develops and maintains process system applications for manufacturing processes.
- Supports investigation teams, identifies opportunities to improve systems and practices, and provides direction to product development teams.
- Provides interpretation of manufacturing data for routine process analysis and monitoring as well as for identification of improvements to manufacturing process performance.
- Designs, implements and analyzes data derived from development and/or pilot scale runs that is intended to solving complex manufacturing problems.
- Leads one or more projects spanning multiple departments and cross-functional areas.
- This role requires the ability to work independently and as part of a team.
- Apply process system engineering to manufacturing processes. i.e. multivariable control, real-time optimization
- Apply statistical process controls to manufacturing processes.
- Support technical investigation teams and ensure timely completion and communication of formal investigations.
- Support technology transfers teams; Provide technical risk assessments for new manufacturing processes with data systems
- Design and interpret data from development and/or pilot plant experiments aimed at solving manufacturing problems; Provide comprehensive written reports
- Develop and implement training for manufacturing staff and members of the Manufacturing Sciences group on process control and optimization
- Keep current on cGMP, regulatory and quality requirements that impact Biogen Idec manufacturing
- Keep current in areas if technical of expertise. Represent Biogen Idec in the biotechnology community and with vendors
- Develop SOPs, as needed, to support cGMP manufacturing and/or pilot plant practices
- Technical expertise in at least one area of biopharmaceutical manufacturing and/or process system engineering including: process control and optimization, primary production, data analysis, experimental design, and statistical process control.
- Broad knowledge of other technical areas within biopharmaceutical manufacturing is expected.
- Working knowledge of computer software packages such as MATLAB, C++, VB.NET, ASP Net, Java, and statistical programs (SPSS, SAS, SIMCA-P) is necessary.
- MPC and RTDB experience will be an asset.
- Project management skills, team leadership experience, and excellent written and oral communication skills are required.
- A strong publication record is desirable.
A Masters Degree in a relevant science or engineering discipline, with 4-8 years of related industry experience; or a PhD in the area of process system/bioreactor engineering with 0-4 years of industry experience.