Job Description
Process Development, Lead role in Pharma
required to manage the execution of project activities (new formulation product / technology development programs), from development through scale-up and through to launch.
The successful hire will manage a number of process development projects, from small scale batches Phase I ? III and necessary scale-ups, working hand in hand with development and manufacturing groups.
Responsibilities of Process Development, Lead role in Pharma
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.
Manage execution of project activities, from development through launch, associated with new formulation product / Technology development programs.
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.
Requirements of Process Development, Lead role in Pharma:
Honours Bachelor?s Degree in; Science, Chemical Engineering or Industrial Pharmacy.
5+ years? experience of process development/engineering, formulation and related commercial scale-up/manufacturing in the pharmaceutical industry.
Proven project management & people management skills.
Proven 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 analysis, sample sizing, Anova, DOE, regression analysis an advantage.
Excellent verbal and written communication skills.
For further details please contact Larry on 01-2302400 / larry@rftgroup.ie
The RFT Group, Biopharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. Facebook, Linked-in, twitter