Collins McNicholas

Are you interested in joining a leading biotechnology company in the Munster area?

Are you energetic, enthusiastic and excited by a start-up environment?

If you are looking to progress your career with a top leader in the industry then I have an exciting opportunity for a QC Scientist.

The individual will be responsible for technical support, guidance, and supervision for release, stability, and in-process testing and assay development. 

Role 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

Role Requirements:

  • Requires PhD in Biochemistry, Chemistry, Biology or related field, with 2+ years of relevant experience / MSc in Biochemistry, Chemistry, Biology or related field with 4+ years’ relevant experience / BSc in Biochemistry, Chemistry, Biology or related field with 8+ years’ relevant experience.
  • Previous experience working in a GMP manufacturing environment is desirable.
  • 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 teamwork. Maintains the highest standards of ethical behaviour.
  • Results and performance driven.
  • 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.

For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4320675 or email aisling.lane@collinsmcnicholas.ie

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