Program Manager - Readiness Lead
- Dublin
- Contract
- Full-time
- Lead cross-functional planning and execution of the Operations Readiness roadmap, from facility design through to PPQ (Process Performance Qualification).
- Collaborate with capital project team as well as site operations functions such as engineering, quality, process development and EHSS teams.
- Design and lead various operational readiness workstreams such as optimal material and process flows, materials requirements for testing and qualification activities, documentation.
- Develop and maintain a readiness timeline identifying key milestones, dependencies, and resource needs.
- Able to perform and lead Gap analysis documentation on site and network practices and drive any mitigation actions to close the gaps.
- Facilitate risk assessments and mitigation strategies tied to operational readiness and manufacturability.
- Coordinate and lead the development of operational procedures, and batch records to support GMP-compliant, efficient startup.
- Serve as the voice of manufacturing operations within cross-functional startup and tech transfer teams, bringing a practical, floor-focused lens to facility and process design.
- Drive continuous improvement initiatives to optimize operational performance and reduce variability during startup.
- 8+ years of experience in biopharma operations, with significant exposure to aseptic manufacturing, sterile drug product filling, and startup or capital projects environments.
- Proven ability to lead cross-functional teams and projects in a matrixed, fast-paced environment.
- Strong knowledge of GMP regulations and practices particularly related to sterile fill-finish processes.
- Excellent communication and organizational skills, with a demonstrated ability to self-start and manage ambiguity in a greenfield or brownfield setting.
- Experience in developing and deploying SOPs, batch records, and training documentation.
- Prior involvement in facility design, commissioning, or startup of drug product operations.
- Experience working with automation and high-speed filling lines for syringes.