Reporting to the Process Development Manager, the successful candidate will provide technical expertise and leadership for new and existing technology based product development programmes.
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.
Design and lead 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.
Manage execution of project activities, from development through launch, associated with new formulation product / Technology development programs.
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 by serving as technical expert for development and processing operations.
Present, where appropriate, technical data to internal / external audit groups (including IMB & FDA) and commercial partners.
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.
Requirements:
Third level qualification in Science, Chemical Engineering or Industrial Pharmacy (or equivalent education/training/experience).
Minimum of 5+ years experience of process development/engineering, formulation and related commercial scale-up/manufacturing in the pharmaceutical industry.
Strong technical and project management skills.
Demonstrated track record in generating technical options to resolve problems, prioritising solutions, selecting optimal solutions and implementing decisions in the pharmaceutical industry.
Strong experience in statistical anaylsis, 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.
Package:
Contract rate dependent on prior experiJob Description
Reporting to the Process Development Manager, the successful candidate will provide technical expertise and leadership for new and existing technology based product development programmes.
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.
Design and lead 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.
Manage execution of project activities, from development through launch, associated with new formulation product / Technology development programs.
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 by serving as technical expert for development and processing operations.
Present, where appropriate, technical data to internal / external audit groups (including IMB & FDA) and commercial partners.
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.
Requirements:
Third level qualification in Science, Chemical Engineering or Industrial Pharmacy (or equivalent education/training/experience).
Minimum of 5+ years experience of process development/engineering, formulation and related commercial scale-up/manufacturing in the pharmaceutical industry.
Strong technical and project management skills.
Demonstrated track record in generating technical options to resolve problems, prioritising solutions, selecting optimal solutions and implementing decisions in the pharmaceutical industry.
Strong experience in statistical anaylsis, 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.
Package:
Contract rate dependent on prior experi
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical