Industry Pharma/Biotech/Clinical Research
Work Experience 4-5 years
City Cork
State/Province Cork
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.
Summary:
The Analytical Sciences department .
is seeking a skilledAnalytical Biochemist and/or Biologist at the Research Associate level to joina team focused on supporting gene therapy & enzyme replacement therapy.
Thesuccessful candidate will be a self-motivated, independent and critical thinkerwho has experience of working in a multi-disciplinary and fast pacedenvironment, and solid communication skills.
The candidate will execute a widevariety of analytical methods and assays for the characterization oftherapeutic candidates in development with a particular focus on testing tosupport clinical and commercial process development teams.
Requirements
Responsibilities:
Primary responsibility: Execute product testing tosupport Drug Substance and Drug Product process development teams
Perform non-routine testing of in-process samples, andfinal product samples of key projects for the TDS processing team
Conduct analytical tests using techniques such as HPLC,UPLC, CE, FTIR, and plate-based methods
Document all test results accurately and in compliancewith Good Laboratory Practices (GLP) and company SOPs.
Collaborate with cross-functional teams including DrugSubstance Technologies, Drug Product Device Technologies, Manufacturing, andQuality.
Provide concise and quantitative analysis of data andinterpretation of experimental results.
Provide effective oral presentations at departmentalmeetings
Report progress to the manager on a weekly basis on eachprogram
Write up experimental plans and results and share withcollaborators and supervisor; present data proactively and regularly in groupmeetings.
Catalogue data/reports electronically in an accessiblemanner for inspections
Required Skills:
Strong understanding of GMP, GLP, and regulatorystandards
Familiar with protein chemistry/function and bioassays
Experienced in cell culture techniques and proteinexpression/activity readout methods
Excellent communication, collaboration and writing skills
Proven data analysis, interpretation and scientificcommunication skills
Proven flexibility and execution skills to deliver in afast-paced, multi-tasking environment
Desired Skills:
Experience in method troubleshooting, qualification, andtransfer
Knowledge of biopharmaceutical development is a plus
Education:
Research Associate 1: Bachelors degree in biologicalsciences and at least 2 years of relevant experience, or 1 year experience withMasters.
Title will be commensurate with experience
Research Associate 2: Bachelors degree in biologicalsciences and at least 3 years of relevant experience, or 2 year experience withMasters.
Title will be commensurate with experience
Equipment:
Operation of standard laboratory equipment forbiochemistry and for cellular assays
Will report to the Sr.
Manager Analytical Services.
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