- Reference: CJ43002yyyyyyy
- Job Type: Contract
- Location: Cork, Munster
- Category: Science, Pharmaceutical & Food
Phd Organic Chemists
Accountability/Scope of Responsibility
• Acquire a detailed knowledge and understanding of the chemistry of the relevant processes including Mechanisms.
• Development History, including boundary conditions.
• Impurity formation and control.
• Complete any laboratory troubleshooting/investigative activities
• Be responsible for the completion of laboratory development projects on schedule for the relevant process/es.
• Actively contribute to development initiatives such as those required to improve process understanding, process control, process capability, robustness, yield and throughput.
• Ensure appropriate tools/metrics are in place to monitor the key technical parameters for the process
• Prepare technical documentation to support manufacturing, e.g. Manufacturing Batch Records, laboratory SOP’s, process steps, PQ protocols, PQ reports, CMC chemistry descriptions, technical training material etc.
• Provide training to the Operations team personnel as necessary.
• Ensure all process changes made have safety and quality considerations as core attributes.
• Lead/participate in rigorous technical risk assessments for plant changes/product introduction
• Carry out necessary investigations of all quality and yield issues.
Lead/contribute to the resolution of technical investigations on plant.
• Liaise with Secondary to ensure all secondary issues are dealt with, e.g. specific customer packaging requirements, specifications, technical issues as they arise
• Liase with procurement to support procurement cost reduction and security of supply projects. Provide technical support to the evaluation and assessment of suppliers
• Provide technical support for Capital engineering projects relating to NCE’s, existing products, and major process re-development.
• Actively participate or lead and coordinate the site input into the Technology Transfer process from R&D or other sites ensuring that the processes/ technologies involved are suitable for commercial production on site.
• Provide chemistry feedback to Chemical Development on early phase NCE’s
• Provide process chemistry input for site impact assessments
• Maintain an active process chemistry knowledge repository ensuring that all product knowledge is maintained, readily accessible and updated.
Quality Responsibilities/Scope of Responsibilities
• Perform duties in a compliant manner and behave in accordance with our Quality Management System requirements.
• Participate fully in our site’s quality initiatives and ensure that all relevant quality standards are adhered to.
• Maintain GMP standards where appropriate to your role
• Read and understand relevant Standard Operating Procedures and Global Quality applicable to role
• Management Policies relevant to your job role.
• Attend training and complete assessments as required.
• Ph.D or a post graduate qualification in a related subject
Green Belt qualification
Preferred Experience A minimum of 3 years experience
For a confidential discussion and more information on the role, please contact Rory on 021 4911063or email firstname.lastname@example.org
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