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 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.
We are hiring a Bioassy Technical Specialist. This is a position requiring someone with strong analyticalexperience to provide multidisciplinary expertise and technical support to theAnalytical Sciences team and commercial testing laboratories. The successfulcandidate will be responsible for leading the effective and efficient runningof Analytical Bioassay and ELISA methodologies both globally and locally,Analytical Method Transfers, Validations, Investigations and Change Control. Inaddition, the successful candidate will be a member of the Analytical SciencesLeadership team governing the Analytical Sciences group. The successful candidate will demonstrate a high level oftechnical leadership, collaboration, coaching and mentoring to facilitate theteam in becoming a high performing organisation and ensuring timely delivery ofprojects. Central to this objective will be the active engagement andcommunication with all internal and external stakeholders. A high level ofinnovation, enthusiasm and drive will also be required to deliver technicalexcellence for analytical methods. Requirements What you will do: Good knowledge of working practices required for working ina Bioassay laboratory (e.g. ELISA, cell biology, cell culture, proteinbiochemistry etc.) Support assay optimisation/investigations within theBioassay area Analytical Technology Transfer Preparation of documentation associated with the projects inaccordance with GDP (good documentation practice) and site procedures. Lead the delivery of projects whilst adhering to projecttimelines using project management tools. Lead cross-functional problem-solving teams fortroubleshooting, and investigations within local Quality, other Sites withinthe network and contract laboratories as required. Commissioning and Qualification of various lab equipment anddesign and execution of assay and equipment validation studies and lifecyclemanagement of Bioassays. Engage in ongoing Bioassay performance monitoring. Prepare, review and approval of technical documents,procedures, CAPAs, change control, deviations, metrics, etc. Actively pursue development opportunities to increase theskill set and experience within the group through continuous education, jobrotation, cross-functional training, Lean Six Sigma, etc Collaborate with internal partners (i.e. other sites,R&D) and externally with CROs What skills you will need: BSc in a relevant Science discipline Experience with ELISA/ Bioassays and leading analyticalmethod validations Self-motivated and ability to work as part of a team withgood project management skills High level written and verbal communications with advancedPC skills Knowledge and experience of operating in a development andcommercial lab environment Project management or qualifications such as, ProjectManagement Professional (PMP) Desired Qualifications/Experience: Knowledge of and experience in applying Six Sigma and Leanmethodologies, Equipment commissioning and qualification.
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