Great opportunity for a Process Chemist to expand their API experience in Cork.
Experienced Process Chemist required for a global pharmaceutical company based in East Cork. This is an initial 12 month contract position.
You will responsible for process development and process improvement activities. The overall objective of this role is to bring scientific and technical knowledge to the value stream.
You role is to identify, manage and participate in process development activities to optimise existing production processes and procedures to improve quality, increase yields, reduce cycle times and costs.
Role and responsibilities:
- Ensure that the work is carried out according to applicable environmental, safety and working regulation and with a strong commitment to promoting work place environment, health and safety.
- Ensure that the work is performed according to applicable GMP regulations.
- Manage the implementation or transfer of new methods into the laboratory.
- Use computer-based modeling, simulation & analysis to look for improvement opportunities and to analyze problems in the API value chain. Identify hazards, assess their relative risk and incorporate recommendations into your process designs. Install and apply innovative technologies solutions.
- Provide technical support to all aspects of the process.
- Owner of the PAT systems in the API value chain.
- Drive implementation Lean/Operational Excellence principles across the Technical Analytical Services department.
- Ensure use of formal problem solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools.
- Attend professional meetings and/or review literature to evaluate and remain current with new technology and guidelines.
- Lead and manage process development activities.
- Liaise on group process development activities
- Initiate and Support process Change Control requests.
- Documentation and qualification of development activities.
- Provide support concerning production processes, critical parameters and process knowledge to Production, QC/QA and Technical Service departments.
- Review and update Master Production documentation.
- Initiate and lead continuous improvement activities utilising lean manufacturing methodology.
- Preparation of production SOP's.
- Process Validation of production processes for finished and intermediate products relating to heparin
- Training of personnel in production processes.
- Investigate and document Deviations and Problem investigations as described in company operating procedures.
- Develop Strong expertise and excellent scientific knowledge of process analytical technology and analytical methods in the Heparin Sodium and Tinzaparin sodium process from mucosa through to finished API.
Education & Experience required:
- Technical or Scientific Masters / PHD.
- 3-4 years' experience in a Technical / Analytical role on a pharmaceutical site regulated by FDA and/or EU regulatory agency.
- Experience in all aspects of investigating/troubleshooting and improving manufacturing processes by performing lab, pilot scale investigations from Protocol writing, execution and report writing through to implementing the changes at full scale in a manufacturing environment
- Excellent technical writing skills.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.