The Senior Manager, Technical Operations will provide oversight of the Technical Operations team supporting drug substance and drug product manufacturing operations. This person will also be responsible for leading the onsite development lab and driving program initiatives to meet business objectives.
Key responsibilities will include:
• Partner with both Operations and Quality to support Commercial products.
• Work with our internal and external partners to implement process improvements.
• Manage a late-stage process development lab and associated laboratory projects.
• Lead the development and implementation of lab scale models of commercial processes.
• Collaborate with site leadership to leverage manufacturing personnel for technical operations initiatives
and to support employee professional development.
• Leads Tech Transfer projects between CMOs and internal stakeholders.
• Supports technical investigations both internally and at external partners
• Responsible for authoring and reviewing CMC documentation for regulatory submissions
• Leads project meetings and technical forums
• Technical lead for new material introductions and raw material/component replacement projects
The successful candidate will have
• PhD/MS/BA or BS in Chemistry, Biology, Pharmaceutical Science, Physics, or related science with a minimum of 5 – 10 years of pharmaceutical or related work experience in the field.
• At least 3 years in a supervisory/lead role preferred.
• Needs to possess excellent oral and written communication skills.
• Advanced knowledge of laboratory procedures is necessary. Individual must demonstrate advanced problem-solving skills and technical competency.
• Must demonstrate the ability to work effectively in a team environment.
• Cross-functional knowledge of process chemistry and bio-manufacturing is desired.
• Chemical Design for Six Sigma knowledge is a plus.
For more details and full job spec please contact Clodagh D’Arcy on 01 9476356 or email details to [email protected]
