LSC have a great contract opportunity for a Technical 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.
KEY RESPONSIBILITIES: Upstream (Cell culture focus) to include media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors and harvest centrifugation/clarification.
Downstream to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration, viral reduction filtration and viral inactivation technologies and DS formulation, bulk fill and storage.
To author and review process technical documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution ABOUT YOU - ARE YOUR SKILLS A MATCH?
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 and or downstream purification processing Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings Ability to present and defend technical and scientific approaches in both written and verbal form Ability to drive for results independently and adapt to rapidly changing priorities Experience of Technology Transfer activities is advantageous For this great opportunity please apply via this advert or contact LSC on to discuss in detail.
Applicants must have a valid work permit for 12 months to apply.
LSC do not provide sponsorship.