About PSC Biotech
Who are we?
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.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which include the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to working in top pharmaceutical client sites in a diverse cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech. We provide unparalleled empowering career development through Learning & Development, in-house training, and mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are being met.
Note: Applicants must be eligible to work full-time here in Ireland. That means EU, UK, as well as Stamp 4 VISA holders are all eligible; visa sponsorship is not provided.
Overview:
The client 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.
An amazing opportunity has arisen for a Manufacturing Bioprocess Associate to provide operational support for manufacturing operations of the client Late Stage and Launch Pipeline products at our new state-of-the-art single-use biotechnology facility. The facility serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives.
Role Functions:
* The Manufacturing Bioprocess Associate will support end-to-end production operations for both Fed Batch and Continuous Manufacturing.
Primary activities/responsibilities:
* Operate equipment according to electronic batch records, sampling plans, and standard operating procedures.
* Work as part of a multi-disciplined, diverse, and dedicated process team where flexibility and teamwork are essential requirements.
* 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.
Required Education, Experience and Skills:
* Level 6 qualification in a science or engineering discipline desired.
* 2+ years experience in a GMP Manufacturing requirement shall be deemed equivalent.
* Ability to work independently and within a cross-functional team.
* Familiarity with contamination control and batch release requirements.
* Familiarity with Emerson DeltaV, Pas X, and the use of Automation in a manufacturing process.
* Experience with various Single-Use technologies in a manufacturing environment.
Preferred Experience and Skills:
* Understanding of Upstream and Downstream Unit Operations for mAb manufacturing.
Reports to: Drug Substance Process Operations Manager
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