LSC have a great contract opportunity for a Tech Services Specialist to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- To provide process expertise in Downstream unit operations to include 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 transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents.
- Data retrieval and review of batch data to support batch review and continued process verification
- 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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
- 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 Downstream processing.
For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 1G or a Stamp 4 visa. We apologize for any inconvenience, as visa sponsorship is not available currently. Thank you for your attention.
Apply via this advert or contact Adam Murphy at LSC on 021-4777329 if you have any more questions about this.