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QC Scientist

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Limerick
  • Sector: Science
  • Date posted: 06/06/2018
  • Job reference: J387663A

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QC SCIENTIST - JOB SPEC

A QC Scientist is required to join a leading biotechnology manufacturing company. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.

This role will be responsible for performing assay development, characterization, optimization, transfer, validation and investigation for QC chemistry group. As well as providing technical support, guidance and supervision for release, stability, and in-process testing and assay development.

This is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Pharmaceutical/Biotech industry.

Essential Duties and Responsibilities

  • Performs assay development/validation for QC Chemistry or Biochemistry groups.
  • Reviews new test procedures and assays.
  • Evaluates and bring in new methodologies/techniques when needed
  • Facilitate assay transfer from R&D and to business partners.
  • Organize analytical assay transfer internally and externally
  • Lead technical troubleshooting and problem investigation.
  • Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance.
  • Participates in training programs for analysts.
  • Represent QC in project teams and provide Quality input across functional areas
  • Oversee Contract Laboratory testing
  • Position requires strong technical and troubleshooting skills in combination with strong communication skills in order to meet QC objectives
  • Requires approximately 30 to 40% of direct time in the laboratory
  • Write and review CMC sections for regulatory submissions

Education

  • Requires PhD in Biochemistry, Chemistry, Biology or related field, with 2+ years of relevant experience
  • OR/ MSc in Biochemistry, Chemistry, Biology or related field with 4+ years' relevant experience.
  • Previous experience working in a GMP manufacturing environment is desirable.

Skills

  • Excellent Communication skills, both verbal & written
  • Experience with electronic systems such as LIMS, SoftMax, Empower, Qumas, Trackwise etc., is an advantage
  • Adaptable and flexible, willing to travel when needed
  • Collaboration and team work. Maintains the highest standards of ethical behaviour
  • Strong analytical ability and associated problem solving
  • Good time management and attention to detail
  • Knowledge and proficient in the use of Microsoft products including, Excel, Word and PowerPoint

Interested?

For more information do not hesitate to reach out to Jack on 01-6455262, or email jack.conway-kenny AT experis.ie

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