
Bioprocess Development Specialist
1 week ago
Job Overview
We are seeking a highly skilled Cell Culture Process Specialist to support the development and implementation of scalable and robust processes for mAb manufacturing.
The ideal candidate will possess technical expertise in one of the following areas: Omic technologies, Bioprocess modeling, or CFD. Recent PhD graduates with a strong background in bioprocessing are encouraged to apply.
Key Responsibilities- Support upstream process development, scale-up, and characterization for mAb manufacturing.
- Develop and establish processes that meet product yield and quality standards.
- Assess risk and implement mitigation strategies during process development and scale-up.
- Collaborate with cross-functional teams on process development, technology transfer, and improvement.
- Participate in technology transfer activities and coordinate with program management and cross-functional teams.
- Provide support for regulatory dossier filing and audits.
- Maintain awareness of latest advancements in science and technology, bioprocessing.
- Analyze upstream data and make technical decisions using statistical knowledge and QbD/DOE concepts.
- Record and review raw data according to GDP principles.
- Prepare work presentations, write technical documents, and procedures (SOPs/IOPs/EOPs).
- Technical expertise in one of the following areas: Omic technologies - Metabolomics, Metabolic Flux Analysis; Bioprocess modeling - Metabolic modeling, process modeling, digital twin for bioreactor or cells; CFD - Computational fluid dynamics to simulate bioreactor mixing.
- Recent PhD graduate from a reputable institution.
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