PSC Biotech Ltd
- Cork city (00) – Ireland
- Main Industry:
- Search Engineering Jobs
- Job ID:
- PSC Biotech Ltd
- Posted On:
- 17 May 2023
About PSC Biotech
Who we are?
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 point 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 of 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 though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Position Title: Bioassay Associate Scientist
-Shift role / 2 cycle Shift
-Reporting to the Team Lead, Bioassay Cork, the person will be focused on executing bioassays and process impurity assays used in the release and stability testing of the large molecule clinical pipeline with responsibility for testing and resolution of product related issues in support of the Bioassay and New Modalities Stability Sciences team.
Main duties and responsibilities:
• Routine release and stability testing of binding assays (e.g. ELISA and TR-FRET), cell-based bioassays (e.g ADCC assays), process impurities and identity assays for pre-clinical and clinical product development.
• Execution of process impurity assays (e.g. residual host cell protein (HCP), residual DNA (PCR techniques) and residual Protein A).
• Completion of documentation in adherence to GMP.
• Testing to support assay validation/qualification and other studies.
• Laboratory support activities (e.g. reagent qualification), routine passaging of cell lines and general housekeeping.
• Support other projects as assigned, e.g.continuous improvement, automation and operational excellence.
• Support troubleshooting and investigations.
• Perform Data Trending to support investigations, demonstrate method capability and product profile.
• Write SOP’s, protocols, work instructions and training modules.
• Other duties as assigned by team lead.
Key Skills and Competencies required:
• Practical analytical laboratory experience in a GLP/GMP environment is advantagous.
• Experience of Bioassay/Cell Culture experience is advantagous .
• Familiar with applicable cGMP and other business compliance regulations.
• Customer focus and results and performance driven.
• Sense of Urgency.
• Ability to work well within team structures and provide leadership.
Education and Experience:
• A minimum of a Degree in Molecular Biology, Biochemistry, Pharmacy or related scientific field is required.
• Knowledge of computer programs such as MS Word, Excel and Minitab.
• Good understanding of quality and attention to detail.
-2 cycle shift – FT onsite lab-based role.
-Shift pattern: Week 1 (Mon Tues Fri Sat Sun)
-Week 2 (Wed Thurs) – 12-hour days (7am – 7pm)
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