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Details

Senior Bioassay Scientist


Reference:AILN-434836 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Senior Bioassay Scientist
Our client, a Dublin based multinational biopharmaceutical company requires a Senior Bioassay Scientist to join their team on a permanent basis. The ideal candidate will have experience in a wide variety of analytical techniques including but not limited to Bioassays, Immunoassays, Cell Culture and Aseptic Technique.

Responsibilities
• Experience in analytical techniques including Bioassays, Immunoassays, Cell Culture and Aseptic Technique
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays
• Participate in the peer review of analytical data
• Provide technical guidance and apply expertise and critical thinking to help to resolve technical issues.
• Lead training of staff on technical aspects of the role
• Develop, revise and implement procedures that comply with appropriate regulatory requirements
• Qualification of analytical equipment and related testing functions
• Participate in Analytical Method Transfers
• Compliance with Standard Operating Procedures and Registered specifications
• Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP
• Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures
• Participate in the generation and update of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications
• Participate in regulatory agency inspections as required
• Plan and implement procedures and systems to maximise operating efficiency
• Manage and contribute to the achievements of department productivity and quality goals

Requirements
• Third level qualification (Degree) in Biology, Biotechnology or related discipline
• 4-5 years of experience in a pharmaceutical/healthcare Laboratory
• Strong background in Bioassays, Immunoassays and Cell Culture is essential
• Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating
• Excellent written and verbal communication skills
• Experience with TrackWise, Change Control Systems, EDMQ and SAP an advantage.
• Knowledge of applicable Regulatory requirements
• Experience with Regulatory inspections and interaction with inspectors is preferable
• Experience leading cross-functional teams
• Experience working with teams and influencing decision
• Skilled in the use of problem solving tools/techniques

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252