Senior Manufacturing Bioprocess Associate - Drug Substance Process Operations
* Industry: Pharma/Biotech/Clinical Research
* Work Experience: 1-3 years
* City: Meath
* State/Province: Meath
* Country: Ireland
Job Description
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, 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 includes 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.
Overview:
By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. The facility 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 Late Stage and Launch Pipeline products at our new state-of-the-art single-use biotechnology facility in Ireland.
This role will involve supporting manufacturing operations on a Shift Rotation basis.
The facility serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives.
Reports to: Drug Substance Process Operations Manager
Requirements
Role Functions:
* The Senior Manufacturing Bioprocess Associate will support end-to-end production operations for both Fed Batch and Continuous Manufacturing.
* Support on-floor manufacturing of pipeline products.
* Operate equipment according to electronic batch records, sampling plans, and standard operating procedures.
* Shift role 24/7 (Onsite).
* Work as part of a dedicated process team where flexibility and teamwork are key requirements.
* Ability to solve problems with a desire to continuously learn, improve and develop.
* 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.
Skills and Education:
* A level 6 with a minimum of 3+ years’ experience in a GMP Manufacturing requirement shall be deemed equivalent.
* Competent in troubleshooting and show practical problem-solving capabilities.
* 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.
* 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.
* Understanding of both continuous and batch fed manufacturing processes.
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