The individual will be responsible for developing cell banking processes, tech transfer and troubleshooting GMP cell bank production, performing cell culture studies in support of and, evaluating new technologies and their implementation. to be used for GMP production of therapeutic proteins. This person will routinely interact with manufacturing, quality control departments and contract manufacturing organizations (CMOs).
Scope of work includes cell expansion, cell banking process optimization and characterization, technology transfer to CMO’s and/or internal manufacturing facilities. The individual applies basic knowledge from various technical areas, industry standards and practices, provides quality and productive output that is consistently timely, reliable and reproducible. The candidate must be customer focused, results oriented, science driven and embrace Shire’s values.
- Execute experiments toward development and optimization of cell banking processes
- Execute experiments to qualify cell counting methods for use in cell banks production and testing.
- Evaluate new technologies for cell banks production and testing.
- Participate in upstream process development activities as needed
- Support establishment of in vitro cell age for cell culture processes
- Documents data accurately in laboratory or electronic notebooks as per established company guidelines/SOPs. Generate technical documents such as reports, protocols, and internal presentations and contribute to regulatory filing documentation.
- Participate in and 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.
- MS: 5-8 years
- BS: 6-10 years
- PhD: 0-4 years
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.
Location/Region: Lexington, MA