This position is responsible for applying QbD principles and scientific knowledge to develop efficient and robust upstream manufacturing processes and establish product and process knowledge. Accountable for timely completion and successful transfer of the processes to either internal or external manufacturing partners. Works and communicates well in multi-disciplinary environments and works without appreciable direction. Exercises considerable latitude in determining assignment objectives. Involved in a wide range of complex problems, requiring the regular use of ingenuity and creativity. In addition, this position will contribute to establishing the infrastructure and business processes in support of process development from discovery through commercial launch.
Job Function and Description
- Provide technical expertise and leadership in planning, designing, and conducting experiments and analyzing data toward development and optimization of cell culture processes that are in line with overall project plan and milestones.
- Manage, monitor, and troubleshoot bench-top bioreactors and related control systems.
- Responsible for documentation and maintenance of experimental data, and generating high quality written study proposals, development reports, and oral presentations.
- Maintain substantial knowledge of state-of-the-art principles and theories and contribute to BioEngineering scientific knowledge base through literature review, conference attendance, and publication.
- Lead evaluation of technologies new to Shire in their potential application.
- Participate or lead upstream process development team, participate drug substance team and other departmental sub teams. Contribute to team meetings, including sub teams, project teams, tech. transfer teams, and departmental meetings.
Education and Experience Requirements
Degree in Chemical Engineering, Biochemical Engineering or other related discipline with minimum years of relevant industry experiences in process development.
- PhD: 0-3years
- MS: 3-6years
- BS: 6-9years
Proven record of technical expertise and troubleshooting. Proven ability to work in a fast-paced environment with demonstrated capacity to juggle multiple competing tasks and demands.
Preferredqualification: Ph.D. in engineering or biological sciences with cell culture process development experience.
Key Skills, Abilities, and Competencies
- Have solid understanding of mammalian cell culture process development, process scale-up, tech. transfer, and GMP manufacturing support.
- Have experience in design-of-experiment and the ability to analyze and interpret data collected.
- Embrace and demonstrate teamwork/collaboration and the ability to communicate appropriately and effectively in both oral and written format.
- Demonstrate personal ownership in executing bioreactor process development, tech. transfer, and manufacturing support.
- Be customer-focused, results-oriented, science-driven, and embrace Shire’s values.
- Have the ability to proactively learn new technologies and mange changes in bioreactor process development and process scale-up.
- Have experience working in a GMP environment.
Complexity and Problem Solving
- Lead cell culture process development, scale-up, and technology transfer activities. Identify and analyze technical problems and then find and implement solutions.
- Apply fundamental engineering and biological principles to practical technical challenges.
- Independently plan, design, execute, and analyze experimental data and provide succinct conclusions and/or recommendations.
- Work closely with his/her supervisor and coworkers in managing multiple work streams and projects. Make sound and timely decisions based on project priorities. Provide expert input to the Upstream Development group in addition to Departmental sub teams.
Req ID: R0017629