Kelly Services are recruiting for an experienced Process Development Chemist for a Dublin based pharmaceutical company. The chemist is required to work in the process development laboratory, providing technical support to plant operations, and other department areas on site.
Candidates must have 3+ years API experience.
- Act as a primary process development contact for the provision of technical support to plant operations, QA, QC, validation, engineering, Health & Safety, and environmental personnel.
- Provide technical support and expertise to production during processing. This involves monitoring of key campaign parameters (yield/quality) and taking appropriate action where necessary, performing real time technical assessments, laboratory investigations and determining the path forward when deviations occur.
- Perform product impact assessments and quality investigations.
- Participate in process and quality risk assessments.
- Apply statistical process control tools in monitoring the manufacturing process.
- Identify process improvement opportunities and support the change with laboratory work where appropriate. Generate technical reports and supporting documentation required to progress the initiative through the change control process. Assist in the management of the process validation.
- Support the Supplier Qualification Process for the introduction of new suppliers or changes to supplier processes.
- Support project management and execution of technology transfer projects for new and existing technologies, processes (API) and methods.
- Support the validation of new processes.
- Pro-actively work to improve co-operation with the Astellas Headquarters Process Development group and to maximize the quantity and quality of development work done.
- Manage and/or support projects and other initiatives, which may be of a technical or non-technical nature.
- Participate in training of staff so that staff are trained to safely and effectively carry out their roles and responsibilities.
- Promote an ethos of and deliver on continual improvement in key business areas
- Ensure compliance with relevant regulations and standards associated with cGMP including data integrity, ISO 14001, EMAS, Health & Safety Legislation, Environmental Legislation, and also all site standards, policies, and procedures. Also, support other sections to ensure such compliance.
- Other issues as directed by your supervisor / manager.
- Educated at a minimum to degree level in a scientific discipline. Education to MSc or Ph.D level would be preferable or alternatively suitable experience in key aspects of the position.
- Minimum of 3 years working in a process support and/or development function in a cGMP environment.
- Has a broad GMP and technical know-how to handle emerging issues.
- Familiar with TrackWise or other quality management systems desirable.
- Strong evidence of problem-solving skills
- Knowledge of technology transfer is preferred but not a requirement.
- Knowledge of regulatory requirements related to pharmaceutical manufacture.
- Strong verbal and written communication skills.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.