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Principal Scientist, Formulation Development

Contract Type: Permanent
Location: Louth
Contact Name: Larry O’Leary
Contact Email: larry@rftgroup.ie

Job Description

Principal Scientist, Formulation Development
Our client is a global leader in veterinary medicine, rapid expansion through a combination of outstanding innovation from its own research and development team as well as its own organic growth has led to vacancy for Principal Scientist role.

The successful candidate will provide strategic direction and support to the Pharmaceutical Development team in the development, scale-up and characterisation of new product formulations coupled with the development and validation of analytical methods to ensure scalability and where required participate in the troubleshooting of product/method issues as part of lifecycle management.

The ideal candidate will be an experienced Formulation Scientist in supporting product development lifecycle, from formulation through to regulatory submission.

Responsibilities for Principal Scientist, Formulation Development:
Preparation and development, scale-up and characterisation of new product formulations, processing methods of a
To participate in the troubleshooting of product / method issues as part of product life cycle management.
To perform all work activities within the required guidelines to ensure compliance with regulatory authorities.
To research new methodologies, processes and products to support improvements in lab efficiency and project range.
Design and execute experimental plans to develop analytical methods.
To lead multiple studies for a range of analytical methods with a high level of complexity/project simultaneously and ensure methods are scalable and transferable to routine use with work executed efficiently and appropriately for successful studies right first time.
Transferring analytical methods to other internal laboratories and sites
Scope and identify new technologies and bring in technologies in line with business needs
Verify method performance meets the requirements defined in the analytical target profile
Contributes to sales meetings to explain technical details and support broad and complex proposals
Proficient with statistical techniques for data analysis
Preparation and approval of test methods, study protocols and study reports
Maintaining a high level of scientific expertise and keeping up to date with current technical and regulatory expectations

Requirements for Principal Scientist, Formulation Development:
Bachelors’ Degree in chemistry, analytical chemistry, pharmacy or related subject
8+ years practical lab experience within a regulated environment with demonstrable experience in formulating both sterile and non-sterile dosage forms.
Demonstrable experience in developing and validating analytical methods for a wide range of dosage form.
Thorough understanding of pharmaceutical quality management systems.
Experience in the use of QbD principles for pharmaceutical development.
Experience in solving technical problems observed during method development and routine method operation.
Knowledge of FDA/EMA practices and guidelines.
Significant experience of HPLC, UPLC techniques.
Experience in generating documentation to support the CMC component of regulatory filings.
Experience in the setting of specifications for drug products.
Experience in Technology Transfer with scale up from laboratory to commercial.
General experience of clinical trials.
Thorough understanding of pharmaceutical quality management systems.
Excellent oral and written communication skills

For further details, please contact on Larry on +353 (0)1-2302400 / 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. www.rftgroup.ie / www.meddevicejobs.ie

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