Our client is a biologics company based in Waterford looking for a Analytical Sciences Analyst who will be responsible for the Analytical Method Development, Transfer and Validation of drug products and the remediation of methods as part of Analytical Life Cycle Management of associated analytical methods. In addition, have responsibility for troubleshooting and supporting complex process and QC investigations. In this role the successful candidate will contribute to developing life changing drug products to help patients fight against disease and directly contribute to providing them with a better quality of life.
- Provide analytical chemistry services and support to our client’s network and site activities.
- Effective interaction with other departments on matters related to raw materials, intermediates and finished batch release and new product introduction.
- In particular, close contact maintained with MSAT groups, Quality Control, Quality Assurance, and Production, Engineering and Project Leaders and network stakeholders.
- Complete project tasks in line with requirement set out in product roadmaps.
- Maintain, update and issue chemical methods and SOP’s in compliance to pharmacopoeial and regulatory requirements.
- Training of the analysts in areas of expertise and knowledge and assist in document generation and updates within the MSAT- Analytical laboratories.
- Analyse data and plan further experiments where required using statistical tools and applications.
- Provide analytical and troubleshooting expertise and complete investigations within the required timeframes.
- Update the MSAT-Analytical Team Leader on potential problems and highlight improvements where possible by use of the normal communication means.
- Ensure all documentation and records are completed.
- Ensure MSAT-Analytical laboratory meets current Good Laboratory Practice (cGLP) requirements.
- Ensure relevant procedures are correctly defined and followed.
- Design and perform troubleshooting and method optimisation tests when required.
- Develop new analytical methods as part of the continuous improvement or updates implemented for the product.
- Generate and execute analytical transfer /validation protocols and write the reports as a result of the executed experiments.
- Be able to logically think and draw conclusions from the experiments performed.
- Demonstrate scientific initiative and creativity towards continuous process improvement for product quality.
- Ensure that critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ) where required.
- Audit and review chemistry test results on a daily basis and ensure compliance with cGLP.
- Checking/auditing laboratory notebooks and analytical reports.
- Ensure compliance to cGMP at all times.
Qualifications & Experience:
- A PhD in Science (Chemistry or Biochemistry preferred) or an MSc/BSc with relevant years’ experience.
- 2-3 years previous experience in a similar role.
- Strong analytical and troubleshooting skills.
- Experience operating to cGMP standards utilizing laboratory equipment.
- Strong technical leadership skills.
- Experience with analytical techniques such as HPLC, UPLC, CE, UV, SDS-PAGE.
- Experience of LIMS, Empower, JMP and other laboratory software would be advantageous.
To apply for this job email your details to email@example.com.