QC Scientist – Limerick | Collins McNicholas

QC Scientist – Limerick

  • Reference: GY45089AO
  • Job Type: Permanent
  • Location: Limerick
  • Category: Science, Pharmaceutical & Food

Summary:  Perform assay development, characterization, optimization, transfer, validation and investigation for QC chemistry group.  Provide technical support, guidance and supervision for release, stability, and in-process testing and assay development.

 

Essential Duties and Responsibilities include, but are not limited to, the following:

  • 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 0-2 years of relevant experience / MSc in Biochemistry, Chemistry, Biology or related field with 3+ 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. 
•    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/company please  email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

Contact Consultant

  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
  • Connect with Amy

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