Job Description
An exciting 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 state-of-the-art single-use biotechnology facility.
Our facility in Dunboyne, Ireland is a premier facility that enables and advances our best work. By integrating leading-edge technology with a dynamic workspace, the facility supports seamless connection and collaboration within and across teams and functions.
The facility is designed to be operated in a multi-product mode, requiring flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change.
Our facility serves as a hub that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel that they belong and that the facility belongs to and is shaped by them.
Responsibilities:
* 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 key requirements.
* 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 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.
Requirements:
* Bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process Engineering.
* 5+ years of experience in the 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 automation in a manufacturing process.
* Proficiency in various Single-Use technologies in a manufacturing environment.
* Problem, Deviation, and Change Management experience.
Preferred Qualifications:
* 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