Senior Manufacturing Bioprocess Associate

Senior Manufacturing Bioprocess Associate

- 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.

Career Advancement

PSC Biotech disrupts the conventional consultancy model by aligning our employee value proposition as one of our 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 mentorship, and constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our clients' expectations regarding quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are met.

Overview:

The client facility is a premier, state-of-the-art facility that enables and advances our best work. 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 client site will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch. The client 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 Senior 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. The Senior Manufacturing Bioprocess Associate will support end-to-end production operations for both Fed Batch and Continuous Manufacturing.

Requirements

Primary Activities/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.
- Ability to solve problems with a desire to continuously learn, improve, and develop.
- Support weekend or out-of-hours work on select timeframes to support manufacturing activities.
- 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.

Education and Skills Required:

- 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 and Skills:

- Commissioning and Qualification experience.
- Understanding of Upstream and Downstream Unit Operations for mAb manufacturing.
- Understanding of both continuous and batch fed manufacturing processes.

Reports to: Drug Substance Process Operations Manager

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