MSD Associate Director Engineering - Large Molecule 

Ireland, Dublin 

468345408

Job Description

What you will do:

• Provision of direct support to drug substance and/or drug product manufacturing sites
• Strategic project leadership for multi-site technical or continuous improvement initiatives
• Supporting and/or leading technology transfer activities at our manufacturing nodes
• Facilitation and leadership of quality risk assessments and after-action reviews
• Leading and/or supporting complex and/or multi-site investigations
• Ensuring best practices are documented, communicated and implemented across manufacturing nodes
• Leading and/or supporting supplier related technical issues
• Support of inspections at manufacturing nodes
• Authoring, reviewing regulatory documents and supporting regulatory responses
• Authoring, reviewing and approving technical study protocols, memos and reports
• Support person-in plant activities for technology transfer and lifecycle management changes
• Providing technical direction in the interpretations of trends observed in process monitoring and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
• Teaching, coaching, mentoring of team members

What skills you will need

• >10 years’ experience in similar Bulk DS and DP Technical Support role in Microbial or Cell culture and/or purification and drug product manufacturing or have demonstrated experience in these areas.
• MSc Degree in Biochemistry, Microbiology, Engineering or a related field. Candidates with a bachelor’s degree in a relevant field with suitable experience will also be considered
• Evidence of Continuous Professional Development and cross skilling.
• Ability to steer internal/external debate and discussions at high levels and guides constituents towards consensus around strategic/policy making topics.
• Drive and support continuous process verification and data management, process performance monitoring program and knowledge management for all products under his/her responsibility

Minimum experience

• Strong technical understanding of the science and engineering behind the process for biologics or vaccine drug substance and/or drug product manufacturing
• Understands the true regulatory requirements and partners with Operations, Quality, and the others to develop more efficient ways to meet these requirements
• Capable of providing strong leadership to several high impact, complex, cross-functional divisional teams and initiatives and to the department
• Must be able to multi-task and work within tight deadlines. This position requires flexibility and the ability to direct a team, work independently, as well as excellent organizational skills
• Strong professional and interpersonal communication skills are required to allow excellent cross functional stakeholder management in an ambiguous environment

So, if you are ready to:

Current Contingent Workers apply

Not Indicated

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