LSC have a great contract opportunity for a Senior Cleaning Validation Lead 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.
If you have 10 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- To provide cleaning expertise in Upstream and Downstream equipment: including parts washers, media vessels, bioreactors, centrifuge, depth filtration/clarification skids, buffer vessels, purification equipment including chromatography, ultrafiltration, viral filtration skids, downstream vessels and supporting process equipment.
- To author and review cleaning related documentation, gap assessments, technical protocols and reports, and cleaning validation documentation, strategy documents.
- Defend cleaning validation strategies and studies during regulatory inspections.
- Provide SME leadership to a team of specialists to ensure delivery of project milestones.
- To identify requirements for laboratory studies to support cleaning decisions, and to liaise closely with 3rd party Laboratories/Process Development / Procurement / MSAT to oversee the design and execution of cleaning studies.
- 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 generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum undergraduate degree in chemistry, biology, engineering or related discipline.
- Minimum of 10 years' experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in Cleaning Validation of cell culture unit operations and/or downstream unit operations. Previous experience of cleaning cycle development or cleaning cycle improvement in a technical role is advantageous.
- Proven expertise in leadership including demonstrated ability to drive for results and lead innovation and change.
- Comprehensive understanding of cGMP requirements for commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Kathy Gillen at LSC on 021 4777329 if you have any more questions about this role!
