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.
- 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 / 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 email@example.com