Senior Specialist Engineering - Large Molecule Technical Operations Site Support

• Dunboyne, Meath, Ireland
• Carlow, Carlow, Ireland
• Brinny, Cork, Ireland
• Swords, Dublin, Ireland

Large Molecule Technical Operations Site Support (LMTO SS) are a global LMTO team that provide skills and expertise to all the Large Molecule manufacturing sites (both internal and external) within our Manufacturing Division. Our mission is to establish new capabilities and processes that significantly improve manufacturing productivity and technical effectiveness of LM sites and technical support teams, ensuring successful project and manufacturing execution. Our team routinely supports athe manufacturing facilities in activities such as technology transfer, authoring site-based documentation, leading manufacturing investigations and trend evaluations, developing and introducing process enhancements, and providing project leadership.

Our team is composed of scientists and engineers who provide skills and expertise to all the Large Molecule manufacturing sites (both internal and external manufacturing) within our Manufacturing Division. The organization routinely supports the manufacturing facilities in activities such as performing technology transfer, authoring site-based documentation, leading manufacturing investigations and trend evaluations, developing and introducing process enhancements, and providing project leadership. Our goal is to continuously deliver outstanding value to our patients through ensuring technical excellence and robust worldwide supply of our companies’ products. In addition to these areas, our team is building additional capabilities to strengthen connections between site and global teams, make problems visible and improve speed of issue resolution. We are working to establish systems and processes that enable sharing of best practices / lessons learned and proactive / standardized approach to problem solving. Our goal is to ensure that the technical capabilities for all manufacturing operations are ready, continuously improved and in position for right first-time operations.

Given the diverse roles that will played by the successful candidate, the role requires high levels of flexibility, adaptability, innovation, enthusiasm and a broad technical knowledge. This is a unique opportunity to support a broad range of the large molecule manufacturing business with the role working across drug substance, drug product, internal and external manufacturing for both biologics and vaccine manufacturing modalities. The successful candidate will gain a vast array of experience in different areas across the large molecule business in this role.

As our team is growing, we are hiring a Senior Specialist to join our team of scientists and engineers. You will report directly to a LM technical lead in the EU and will support the large molecule business both regionally and to the and broader global network. Given the diverse roles that will played by the successful candidate, the role requires high levels of flexibility, adaptability, innovation, enthusiasm, and a broad technical knowledge base across multiple different areas.  The position will be located at one of our company's sites and will involve primarily working remotely from a site but with flexibility to work virtually. You may be required to be available to travel to sites within Europe and/or North America, at approximately 10-25%. 

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• 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
• Actively participates in a culture of continuous improvements and process optimization
• 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.

Is this the role for you? 

Are you someone who enjoys working in a diverse role? Do you have experience in large molecule manufacturing and GMP operations? Are you interested in expanding your skillset into multiple different areas of the large molecule manufacturing business?

Skills/Experience

The successful candidate should have the correct blend of education, skills, experience and positive energy to meet the diverse needs of the role

Key elements of this role include supporting team/partner interactions, supporting change management, deviations/investigations, and supporting continuous improvement initiatives.

In order to excel in this role, the ideal candidate will have:

• A BSc, MSc or PhD in a science or engineering field ideally specializing in the life sciences areas
• Have a deep understanding of the science and technology behind large molecule manufacturing processes
• Possess a deep understanding of manufacturing/operational GMP (Good Manufacturing Practice) including change control, quality risk management, quality notifications and conducting detailed and complex investigations
• Demonstrated experience and knowledge in cell culture with emphasis on mammalian cell culture
• Demonstrated experience with data analytics, statistical process control and multivariate analysis
• Demonstrated experience in regulatory filing authoring, regulatory inspection support and/or regulatory responses and interactions
• Demonstrated experience in large-scale validation and process characterization
• Strong problem-solving skills and a hands-on approach to problem solving.
• Demonstrated experience in leading and/or managing projects
• Ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it
• Ability to work independently and on own initiative with minimal direction from management
• Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required
• Enthusiasm and initiative-taking ability needed for continuous learning and its applications
• Working understanding of analytical methods to characterize biopharmaceutical processes and/or US/EU regulatory requirements

As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. 

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation 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