An amazing opportunity has arisen for a Cell Culture Process Operations Manager to join our team, overseeing Cell Culture Expansion operations for Cell Bank manufacturing and Biologics Drug Substance manufacturing.
Our facility in Dunboyne, Co. Meath is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. Our Dunboyne site will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch. The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change.
Bring energy, knowledge, innovation and leadership to carry out the following:
- Inspire Diversity and Inclusion – building working effective working relationship within a cross-functional team across different cultures and backgrounds.
- Contributes to the overall goals of the team by excelling at their individual role and taking initiative to improve their own leadership and technical/functional skills.
- Implement and oversee tier 0 and represent the area(s) at tier 1 and tier 2, ensuring appropriate level of preparedness of any escalations, fostering a culture of openness, collaboration, and attention to detail to achieve schedule/project task delivery.
- Recognizing that action is required and working to generate alternatives, generate options and choosing effective options, knowing when other stakeholders support is needed.
- Act as first level support in the event of problems on the manufacturing floor.
- Maintain area in GMP Compliance and maintain team training. Collaborate with other teams or departments to ensure cross-functional compliance.
- Oversee the development of GMP Documentation such as: Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and SOPs.
- Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environment goals.
- Influences, partners, and collaborates with other colleagues within and outside their team to build trust encourage two-way communication and strengthen relationships.
- Change management leadership demonstrating adaptability and openness to change, exploring the benefits and collaborating with others to make it effective.
As a people manager you will:
- Be responsible for setting performance goals, conducting performance evaluations, and identifying training and development opportunities for your team.
- Provide your team with the tools and development opportunities (including educational assistance, job rotation, cross-functional training, Six Sigma) to make them successful.
- Assessing workload, identifying gaps or imbalances, and reallocating resources or making hiring decisions to optimize staffing levels and ensure efficient operations.
- Foster a feedback culture within the team or organization, encouraging open and honest communication.
In order to excel in this role, you will more than likely have:
- Bachelor’s degree or higher in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
- 6 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components). Position level will scale with experience level of candidate.
- Experience and understanding of Cell Culture Cell Expansion process of Cell banks and Biologics Drug Substance Upstream Unit Operations
- Competent in analysing complex situations and show practical problem-solving capabilities.
- Ability to work independently and within a cross-functional team.
- Demonstrated experience in QRM, Investigations and Problem solving . Deviations, Investigations, and Change Management experience
- Familiarity with contamination control and batch release requirement
- Experience and understanding of systems such as SAP, Emerson DeltaV, MES PAS -XT, and the use of Automation in a manufacturing Process
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough inn
ovation is when diverse ideas come together in an inclusive environment.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today
