Job description

About Your New Employer

• Highly focused research-driven biopharmaceutical company.
• Employs roughly 2,600 people across 9 Irish sites.

About Your New Job

• The Process Scientist will work within the Site Technology team - they will be tasked with support and leading scientific, engineering, and operational leadership programs for the introduction of new products into the commercial facility.
• This role will involve high levels of cross functional collaboration, technology transfer, process scale up, process performance monitoring and optimization and continuous improvement.
• The Process Scientist will Act as Subject Matter Expert (SME) for fill finish operations and processes.
• The role will contribute to process understanding, manufacturing best practices for filling technology with focus on the continuous improvement.
• You will be tasked with providing technical input to technology transfer related documents (e.g., clinical, and commercial Validation protocols, batch records.
• The role will also support all aspects of new technology introduction, plant performance, process improvements, cGMP compliance and troubleshooting as part of the product support role during the commercial life span of the product.
• You will support the performance of validation activities deemed within the scope of Site Technology, including cleaning, laboratory equipment and process validation.
• The Process Scientist will be tasked with supporting the Site Technology department in meeting departmental and site KPI’s
• Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues.
• Provide SME input to aseptic filling and visual inspection, including technical assistance and deviation investigation.
• You will Manage and lead the startup activities, will provide investigational support, lead and/or contribute to STE lab studies.
• Provide direction and leadership with respect to future process improvement activities.
• Assist in the selection of the appropriate technologies to support the product manufacture.
• Support/lead the selection process for introduction of new analytical/process equipment and the process of the introduction of new methods and procedures.
• Develop SOPs to support the new equipment and methods.
• Liaise/co-ordinate/support the validation activities associated with the introduction of new equipment, or technologies.

What Skills You Need

• 3rd level technical/scientific qualification in biochemistry, Chemical, biochemical engineering, or related field with 4+ years relevant experience to Ph.D level desirable.
• Aseptic drug product experience in sterile fill finish operations and/or DP visual inspection and defect library creation and maintenance is highly desirable.
• Ability to manage both projects and day to day activities. Ensure that priorities are effectively established and controlled.
• Experienced in cGMP and large-scale manufacturing equipment and practices and with the transfer of technology to cGMP operations.

What’s on Offer

• Long Term contract with a competitive salary.
• Annual Bonus.
• Healthcare.

What’s Next

• Apply now by clicking the “Apply Now" button or call me, Ben Byrne on +353 1 4744688.
• Or if the job isn’t quite right but you are looking for something similar, please get in touch

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