- Reference: 43775
- Job Type: Permanent
- Location: Offaly, Roscommon, Westmeath
- Category: Science, Pharmaceutical & Food
•Prepare and execute experimental programs, for use in formulation/process development activities, involving investigational studies to provide indicative process/analytical data for formulation/Process selection and identification of critical process parameter effects. Analyse the process and analytical data generated by these programs and report on same.
•Develop and execute process development activities focused on study of critical parameters to ensure that process conditions, at all scales, are consistent and not at “edge of failure”.
•Develop, execute and refine the methodology required for the generation of successful scale-up/optimisation process models. These models are required to accurately establish process operating windows at relevant scale and identify appropriate in-process operating ranges to maintain both product quality and production efficiency.
•Prepare, execute, analyse and control all Process Development documentation required during related development/scale-up activities.
•Analyse and provide resolution of technical issues.
•Generate documentation to support product design and implementation activities within a cGMP environment.
•Support FDA pre-approval and post-approval inspections for development and processing operations.
•Present, where appropriate, technical data to internal / external audit groups (including IMB & FDA) and commercial partners.
•Ensure all Company and departmental policies and procedures are adhered to.
•Third level qualification in Science or Engineering
•Minimum of 7+ years’ experience of process development/engineering, formulation and related commercial scale-up/manufacturing in the pharmaceutical industry.
•Strong technical and project management skills.
•Demonstrated ability in generating technical options to resolve problems, prioritising solutions, selecting optimal solutions and implementing decisions.
•Strong experience in statistical analysis, sample sizing, Anova, DOE, regression analysis an advantage
•Adaptable to changing priorities.
•Excellent verbal and written communication skills.
•Proven track record in current role is essential.
For a confidential discussion and a more detailed job description (or more information on the role), please contact Donie Shine – firstname.lastname@example.org or call 0906478104.
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