Sr. Process Enginer
The Senior Process Engineer position will focus on the process for directed differentiation of pluripotent cells to terminally differentiated cells. This position will prove technical expertise within the Process Sciences group to develop, optimize, and scale up processes. This person will exercise judgment in the planning and execution of complex methods and procedures. He or she will develop strategies to ensure timely achievement of goals. This position will collaborate closely with other Research & Development groups.
Skills and responsibilities:
- Develop large-scale, robust and consistent processes for expansion and differentiation of human pluripotent stem cells.
- Evaluate new cell culture conditions and backup reagents.
- Participate in developing appropriate in-process and release assays in conjunction with Cell Biology Scientists.
- Develop appropriate QC specifications for raw materials, intermediates and final products.
- Collaborate with the Manufacturing group to establish the required product infrastructure (i.e. Bill of Material, Labels, Certificate of Analysis, Manufacturing Process documents).
- Develop and manage product specification and custom requirement studies to stated requirements and specifications with strong emphasis on statistical validity, analysis and presentation of the data.
- Write protocols, technical reports, and SOPs, and develop appropriate documentation for processes.
- Participate in technology transfer of processes to the Manufacturing group.
- Participate in multidisciplinary technical project teams.
Qualifications:
- A PhD degree in Bioengineering, Chemical Engineering, Biological Sciences or Molecular Biology with three years of industry experience or equivalent.
- Proven track record in process development and experience as a member of product development teams required.
- Demonstrated scientific expertise with cell culture, cell differentiation and general molecular biology skills as well as process optimization under a Design Control System and statistical analysis.
- Hands-on experience with large-scale cell culture-based processes and a range of techniques such as automation, perfusion and fed-batch methods are strongly desired.
- Skilled with various techniques including immunocytochemistry, flow cytometry, ELISA and real-time quantitative PCR.
- Experience with Manufacturing systems, ISO and GMP regulations.
- Strong organizational, troubleshooting, and interpersonal skills along with excellent oral and written communication.
- Ability to work in a fast-paced, collaborative team and adapt to a flexible work schedule due to the nature of cell culture.
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