Biopharmaceutical Technical Specialist
2 days ago
About the Role:
We are seeking a highly skilled Biopharmaceutical Technical Specialist to join our team at Pe Global (UK). The successful candidate will have primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS).
The Technical Services Specialist will provide processing expertise to support the technology transfer, process validation and routine commercial manufacturing for Downstream manufacturing.
Key Responsibilities:
- To provide process expertise in Downstream purification process: buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill.
- To author and review process technical documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents.
- To lead or support the continuous process verification program at ADMF.
- To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements.
- To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
- To identify and implement process improvements, e.g. yield, cycle time reduction.
- To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
- May be required to work periodically out of normal business hours during periods of engineering and validation batch execution and provide on-call support to manufacturing.
Requirements:
- BSc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
- Experience of authoring CMC sections of regulatory submissions.
- Minimum 3+ years' experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization.
- Technical and operational knowledge of multiple unit operations in cell culture processing.
- Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
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