LEAD PAT SPECIALIST, PROCESS
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Job Reference Number |
14563008 |
Client ID: |
RI/RFT103PDELOL |
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Posted On: |
Jan 28 2012 |
Location: |
KILDARE, WESTMEATH |
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Job Type: |
Permanent
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Salary: |
NEG |
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Benefits: |
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Lead PAT Specialist, Process
required to manage the execution of project activities (new formulation product / technology development programs), from development through scale-up and through to launch.
Responsibilities for Lead PAT Specialist, Process :
Design and lead process development activities ensuring that process conditions are consistent, for all new products.
Prepare and execute experimental programs, for use in formulation/process development activities.
Analyse the process and analytical data generated by these programs and report on same.
Develop, execute and refine the methodology required for the generation of successful scale-up/optimisation process models.
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 technical data to internal / external audit groups (including IMB & FDA) and commercial partners.
Requirements for Lead PAT Specialist, Process :
Honours Bachelor’s Degree in; Science, Chemical Engineering or Industrial Pharmacy.
7+ years’ experience of process development/engineering, formulation and related commercial scale-up/manufacturing in the pharmaceutical industry.
Proven project management & people management skills.
Strong experience in statistical analysis, sample sizing, Anova, DOE, regression analysis an advantage.
Excellent verbal and written communication skills.
Please contact Larry on 01-2302400
The RFT Group , Biopharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.