Industry Pharma/Biotech/Clinical Research
Work Experience 1-3 years
City Dublin
State/Province Dublin
Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm foundedin ****, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide.
We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.
'Take your Career to a new Level'
PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry.
We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.
Employee Value Proposition
Employees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression.
We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.
Overview:
Reporting through the site Process Sciences Lead,Manufacturing Science and Technology and based at thethe Scientist's responsibilities include, butare not limited to the following:
Requirements
Responsibilities:
Supporting and executing experimental design, dataanalysis and interpretation to resolve complex cell culture deviations.
Supporting process improvement and troubleshooting withend-to-end product focus.
Provide technical support investigations, new processintroduction or change implementation in commercial manufacturing operations.
Authoring and reviewing development operating proceduresand technical reports.
Supporting global regulatory submissions as needed.
Applying LeanSixSigma tools in the Process Sciences groupby:
Securing continuity of an appropriate LSS/CEM level ofknowledge.
Facilitating problem solving & risk assessment (FMEA)projects/meeting.
Making problems visible and strive for continuousimprovement.
What skills you will need:
A master's degree (or higher) in BiologicalSciences/Chemistry /Chemical Engineering/Biological Engineering.
0-3 years' experience in the Biopharmaceutical industry(preferably practical experience of cell culture processing).
Experience in drug substance process development, processcharacterisation studies, mammalian cell technology, biochemistry, cellbiology, fluid mechanics and process modelling.
Experience in executing experimental programs in thelaboratory.
Working knowledge of statistical methods for DOE designand 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 andLean methodologies
Desirable evidence of Continuous Professional Development
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