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 021-4777329 to discuss in detail.
Applicants must have a valid work permit for 12 months to apply. LSC do not provide sponsorship.
