MSD Cell Culture Process Operations Manager 

Ireland 

368603835

Job Description

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

ovation is when diverse ideas come together in an inclusive environment.

please apply today

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No Travel Required

Not ApplicableNot Indicated

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