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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior Bioassay Specialist


Reference:SCAQIG-313451 Location: Carlow
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Biochemist, Molecular Biologist

Senior Bioassay Specialist
Our client, a global healthcare company, are currently recruiting a Senior Bioassay Specialist to join their biotech site. As Senior Bioassay Specialist You will be responsible for coordinating QC Laboratory activities relating to Lab start up, method transfer and product testing work. This is a senior position where you will work with key stakeholders within the business.


Responsibilities

  • Participate in the method transfer and or validation of analytical techniques including ELISA, Bioassay, Immunoassay Cell Culture and Cell Based Assays
  • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays
  • Provide technical guidance and apply expertise and critical thinking to help to resolve technical issues
  • Direct training of junior team members 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
  • Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP
  • Ensure timely completion of Laboratory Investigation Reports and deviations
  • Participate in the generation and update of SOP’s, trend data, investigations, nonconformances, validation protocols, reports, method validation/verifications and equipment qualifications
  • Provide support with audit/inspection requirements to ensure department compliance/readiness
  • Apply Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions

Requirements
  • 5 years of experience in a similar role within the pharmaceutical industry
  • A relevant master’s in science or other relevant area is desired
  • Experience in Laboratory ELISA/ Bioassay method transfers, validations and investigations essential
  • Experience in SoftMax Pro software is desirable
  • Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices
  • Ability to mentor lab analysts
  • Collaborate effectively with analytical partners in the network
  • Knowledge of relevant GMP and Data Integrity standards