Overview
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
An amazing opportunity has arisen for a Manufacturing Bioprocess Associate to provide operational support for manufacturing operations of the Late Stage and Launch Pipeline products at our new state-of-the-art single-use biotechnology facility in Dunboyne, Ireland.
Reports to: Drug Substance Process Operations Manager
Responsibilities
* The Lead Manufacturing Bioprocess Associate will support end-to-end production operations for both Fed Batch and Continuous Manufacturing.
* Lead/Guide team members to support on-floor manufacturing of pipeline products on a shift rotation
* 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.
* 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 in cross-functional teams to collaboratively ensure compliance
Education
* Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
Experience & Skills
* 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 SingleUse 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
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Research, Analyst, and Information Technology
#J-18808-Ljbffr