About PSC Biotech
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. We serve 350 clients across more than 23 countries worldwide, providing cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services.
Take your Career to a new Level
PSC Biotech disrupts the conventional consultancy model by offering a unique employee value proposition, including the opportunity to work with talented professionals in the Pharma/Biotech industry. We provide permanent contracts that offer exposure to top pharmaceutical client sites in diverse cultural settings.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech. We foster career development through in-house training, mentorship, and continuous guidance to facilitate growth. Our goal is to create high-performing teams that exceed client expectations in quality, stay within budget, and meet deadlines.
Overview
Our facility integrates leading-edge technology within a dynamic, activity-based workspace to support seamless collaboration across teams. It will provide biologics drug substance manufacturing for clinical supply, registration, and commercial launch, designed to be operated in a multi-product mode to adapt to pipeline changes.
An exciting opportunity has arisen for a Manufacturing Bioprocess Associate to support manufacturing operations of late-stage and launch pipeline products at our new state-of-the-art single-use biotechnology facility in Ireland. This role involves supporting manufacturing operations on a shift rotation basis.
The facility values diversity and aims to attract, recognize, and integrate people from varied backgrounds and perspectives.
Reports to: Drug Substance Process Operations Manager
Requirements
Role Functions:
1. Support end-to-end production operations for both Fed Batch and Continuous Manufacturing.
2. Work on a 24/7 shift basis onsite.
3. Assist in manufacturing pipeline products during shift rotations.
4. Operate equipment following electronic batch records, sampling plans, and SOPs.
5. Collaborate within a multidisciplinary, diverse, and dedicated process team, demonstrating flexibility and teamwork.
6. Support weekend or out-of-hours work as needed to support manufacturing activities.
7. Maintain strict adherence to safety and compliance standards.
8. Assist in authoring electronic batch records, sampling plans, work instructions, and SOPs.
Skills and Education:
* Level 6 qualification in a science or engineering discipline preferred.
* At least 2 years of GMP manufacturing experience or equivalent.
* Ability to work independently and within a team.
* Knowledge of contamination control and batch release requirements.
* Familiarity with Emerson DeltaV, PAS X, and manufacturing automation.
* Experience with Single-Use technologies in manufacturing.
Preferred Skills:
* Understanding of upstream and downstream unit operations for mAb manufacturing.
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