About PSC Biotech
We are a leading biotechnology 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 over 23 countries worldwide.
Our Mission
We provide cloud-based software solutions for quality management and regulatory inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
Job Description
We are seeking a Senior Manufacturing Bioprocess Associate to provide operational support for manufacturing operations of late-stage and launch pipeline products at our new state-of-the-art single-use biotechnology facility.
Key Responsibilities
* 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 with a desire to continuously learn, improve, and develop.
* Support weekend or out-of-hours work on select time frames to support manufacturing activities.
* Maintain strict adherence to safety and compliance culture on site.
Requirements
Education: Level 7 qualification in a science or engineering discipline desired. A level 6 with a minimum of 3+ years' experience in a GMP Manufacturing requirement shall be deemed equivalent.
Skills: Competent in troubleshooting and problem-solving, ability to work independently and within a cross-functional team, familiarity with contamination control and batch release requirements, and proficiency in various Single-Use technologies in a manufacturing environment.
Preferred Experience: Commissioning and Qualification experience, understanding of Upstream and Downstream Unit Operations for mAb manufacturing, and understanding of both continuous and batch fed manufacturing processes.
Reports to:
Drug Substance Process Operations Manager