
Cell Development Specialist
5 days ago
**Job Overview**
Our organization seeks a skilled Cell Culture Specialist to support upstream process development, scale-up, and characterization for monoclonal antibody manufacturing.
Key Responsibilities:
- Develop and establish scalable and robust processes to meet desired product yield and quality standards.
- Conduct risk assessments and implement mitigation strategies during process development and scale-up activities.
- Collaborate with cross-functional teams within research and development and other departments for technical discussions related to process development, technology transfer, and process improvement initiatives.
- Participate in technology transfer activities, coordinate with program management, and cross-functional teams to deliver on project timelines.
- Provide support for regulatory dossier preparation, filing, and audits.
- Stay updated on the latest advancements in science and technology, bioprocessing, and apply statistical knowledge in using quality by design (QbD) and design of experiments (DOE) concepts in upstream development.
- Ensure thorough data analysis for assessing upstream data and supporting technical decisions.
- Record and review raw data in accordance with good documentation practices.
- Prepare work presentations, write technical documents (process protocols, technical/development reports), and procedures (standard operating procedures, instrument operation procedures).
- Coordinate within and across teams for smooth functioning of laboratory activities.
**Required Skills and Qualifications:**
The ideal candidate will possess technical expertise in one of the following areas:
- Omics technologies – Metabolomics, metabolic flux analysis.
- Bioprocess modeling – Metabolic modeling, process modeling, digital twin for bioreactor or cells.
- Computational fluid dynamics (CFD) – to better understand and simulate bioreactor mixing.
Recent PhD graduates will be considered for this role.
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