Our client in north Dublin is seeking to hire an Analytical Research & Development (AR&D) Associate Director on a permanent basis.
This position is based at the R&D Centre in Swords, Co Dublin. The R&D Centre has co-located technical expertise, including chemical, analytical and engineering expertise that supports the development and manufacture of clinical and commercial products (small molecule APIs).
The AR&D Associate Director will be responsible for providing leadership and technical expertise for all aspects of analytical methodology development, transfer, qualification and troubleshooting pertaining to the manufacture of small molecules API and intermediates. The role will involve significant cross functional collaboration with other functions including Marketing, Operations, Quality, EHS and external stakeholders/customers working towards the flawless manufacture of existing and new products.
Reporting to the Research & Development Director, the successful candidate will be the overall site lead for the transfer, development, and troubleshooting of analytical methodology.
Responsibilities include but are not limited to:
- Provide leadership and technical expertise to ensure successful development and validation of phase appropriate analytical methods.
- Define and manage the analytical qualification strategy on a project-basis, based upon technical data, resources and capacity planning.
- Mentor and coach a highly skilled professional team and champion team's personnel development.
- Mentor and coach a highly skilled professional team and champion team's personnel development.
- Liaise with Marketing group and customers on a regular basis to ensure seamless projects execution.
- Ensure GMP Compliance of laboratory operations and documentation, including review and approval of protocols, reports and change controls.
- Manage the analytical cleaning method validation programme.
- Support release of clinical material.
- Manage reference standard qualification and certification program.
- Manage the calibration program for R&D analytical instrumentation.
Champion the implementation of new analytical tools and technology to enhance the analytical capability of the site.
- Provide the required analytical expertise to lead and support investigations.
- Provide the required analytical expertise for defining analytical testing technique for discovery stage compounds.
- Partner with QC to ensure seamless transfer and use of analytical methods in the QC Laboratory.
- Partner with R&D Chemistry on a project basis to meet customers' requirements.
- Represent AR&D in customer visits, audits and Regulatory authority inspections.
- Seek opportunities to continually drive performance, with particular emphasis on right first time, speed and agility.
- Drive the laboratory asset management plan relating to the purchase, maintenance, installation and utilisation assessment of new and existing instruments in the AR&D group.
- Support the management of the R&D budget.
The successful candidate will possess strong technical skills in laboratory analysis and technique and people Management. Candidates should hold a post-graduate qualification in Chemistry or related discipline and at least 10 years' experience in the Pharmaceutical industry, preferably in an API environment. Analytical and Chemistry experience in a GMP-regulatory environment essential.
Excellent communication and organisational skills couple with previous supervisory experience and proven ability to drive performance of team are a pre-requisite.
For further information please contact Dominic on 01-645-5254 or click 'apply'.
