Job Description
An amazing opportunity has arisen for a Lead Manufacturing Bioprocess Associate to provide operational support for manufacturing operations of our Late Stage and Launch Pipeline products at our new state of the art single use biotechnology facility in Dunboyne, Ireland.
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 facility 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.
Our Dunboyne facility serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in the Dunboyne, but that the facility belongs to and is shaped by them.
What You Will Do
Bring your energy, knowledge, and innovation to:
* Lead/Guide team members within a process team in one or more unit operations
* Provide guidance, coaching and mentoring to the rest of the production team
* Operate equipment according to electronic batch records, sampling plans and standard operating procedures.
* Work as part of a dedicated process team where flexibility and teamwork are a key requirement.
* Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
* Support weekend or out of hours work on select time frames to support manufacturing activities.
* Conduct all work activities with a strict adherence to the safety and compliance culture on site
* Support the Authoring of electronic batch records, sampling plans, work instructions and standard operating procedures.
* Lead, facilitate and participate daily on cross-functional teams to collaboratively cover compliance topics.
Required Education, Experience and Skills:
* Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
* 5 years + Biotech Industry (bulk manufacturing of pharmaceutical or biological components)
* Competent in troubleshooting and show practical problem-solving capabilities.
* Ability to work independently and within a cross-functional team.
* Understanding of multi column chromatography concepts
* Familiarity with contamination control and batch release requirements
* Familiarity with Emerson DeltaV, Pas X, and the use of Automation in a manufacturing Process.
* Proficiency in various Single Use technologies in a manufacturing environment
* Problem, Deviation, and Change Management experience.
Preferred Experience and Skills:
* Commissioning and Qualification experience
* Experience of Upstream and Downstream Unit Operations for mAb manufacturing with in depth knowledge of key unit operations.
* Understanding of both continuous and batch fed manufacturing processes
* Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits.
Reports to:
Drug Substance Process Operations Manager
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: No Travel Required
Flexible Work Arrangements: Not Applicable
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): N/A
Job Posting End Date: 02/28/2025
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R332185
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