- Reference: GY47019
- 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
• 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. 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 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: email@example.com