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Pharmaceutical Manufacturing Support Expert
1 week ago
We are seeking a highly skilled Technical Services Specialist to join our team at Pe Global (UK). The successful candidate will have a strong background in biopharmaceutical manufacturing and a proven track record of supporting technology transfer and process validation.
The role involves working closely with cross-functional teams to ensure successful facility startup and process qualification. You will be responsible for providing technical support for new/existing drug substance manufacturing processes, as well as leading or supporting the continuous process verification program at ADMF.
The ideal candidate will have excellent communication skills, a detail-oriented approach, and the ability to work effectively in a fast-paced environment.
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 support changes in raw materials and consumables.
- 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.
