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Process Scientist - Dublin, Ireland - PSC Biotech Ltd
Description
Job DescriptionAbout 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.
Job Title: Process Scientist
Role Description:
Reporting through the site Process Sciences Lead, Manufacturing Science and Technology and based at the client site.
Requirements
Role Functions:
· Supporting and executing experimental design, data analysis and interpretation to resolve complex cell culture deviations.
· Supporting process improvement and troubleshooting with end-to-end product focus.
· Provide technical support investigations, new process introduction or change implementation in commercial manufacturing operations.
· Authoring and reviewing development operating procedures and technical reports.
· Supporting global regulatory submissions as needed.
· Applying Lean Six Sigma tools in the Process Sciences group by:
· Securing continuity of an appropriate LSS/CEM level of knowledge.
· Facilitating problem solving & risk assessment (FMEA) projects/meeting.
· Making problems visible and strive for continuous improvement.
Experience, Knowledge & Skills:
· 0-3 years' experience in the Biopharmaceutical industry (preferably practical experience of cell culture processing).
· Experience in drug substance process development, process characterisation studies, mammalian cell technology, biochemistry, cell biology, fluid mechanics and process modelling.
· Experience in executing experimental programs in the laboratory.
· Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
· Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
· Knowledge of and experience in applying Six Sigma and Lean methodologies
· Desirable evidence of Continuous Professional Development.
Qualifications & Education:
· A master's degree (or higher) in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering.
#LI-EL1
Requirements
Role Functions: · Supporting and executing experimental design, data analysis and interpretation to resolve complex cell culture deviations. · Supporting process improvement and troubleshooting with end-to-end product focus. · Provide technical support investigations, new process introduction or change implementation in commercial manufacturing operations. · Authoring and reviewing development operating procedures and technical reports. · Supporting global regulatory submissions as needed. · Applying Lean Six Sigma tools in the Process Sciences group by: · Securing continuity of an appropriate LSS/CEM level of knowledge. · Facilitating problem solving & risk assessment (FMEA) projects/meeting. · Making problems visible and strive for continuous improvement. Experience, Knowledge & Skills: · 0-3 years' experience in the Biopharmaceutical industry (preferably practical experience of cell culture processing). · Experience in drug substance process development, process characterisation studies, mammalian cell technology, biochemistry, cell biology, fluid mechanics and process modelling. · Experience in executing experimental programs in the laboratory. · Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software) · Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus. · Knowledge of and experience in applying Six Sigma and Lean methodologies · Desirable evidence of Continuous Professional Development. Qualifications & Education: · A master's degree (or higher) in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering. #LI-EL1
