Allergan Pharmaceuticals Ireland, based in Westport, Co Mayo and with headquarters in Irvine, California is a specialised global pharmaceutical company that develops and commercialises innovative products for eye care, neuromodulator, skin care and other speciality markets. In addition to its discovery-to-development research programmes, Allergan has global marketing and sales capabilities in over 100 countries that deliver value to our customers, satisfy unmet medical needs and improve peoples lives. Due to ongoing development, we currently have a vacancy for a Manager of our Analytical Chemistry Division.
The successful candidate will have supervisory, scientific and technical responsibility for overseeing the auditing, organizing, coordinating and updating of analytical test methods used to support the release and stability testing of marketed products world wide. Significant experience in analytical validation and global regulatory requirements, especially pertaining to high-performance liquid chromatographic (HPLC) test methods is critical. This role requires significant experience in 'hands on' methods development and validation strategies to meet global cGMP and ICH requirements. In addition, the position requires analytical data interpretation, excellent technical writing and project management skills.
Supervises the auditing of existing marketed product quantitative and qualitative analytical test methods to identify current regulatory deficiencies. Designs and supervises the writing of product specific method validation protocols to address identified regulatory deficiencies;
Supervises both internal analytical staff and contract analytical laboratories executing analytical method development and validation activities for marketed products within a GMP environment;
Reviews, edits and issues detailed written analytical test procedures and validation reports that meet global regulatory requirements;
Makes oral presentations of project status;
Excels as analytical spokes person for all manufacturing site analytical test methods;
Fosters productive relationships with contract analytical and internal Quality Control laboratories.
Education Level and Experience:
Ph.D. in Chemistry, Biochemistry or related scientific discipline;
Minimum 5 years experience working in a cGMP environment including
- analytical leadership in validation of late-stage and/or commercial product analytical methods
- quality control experience with commercial pharmaceutical products
Demonstrated technical writing proficiency producing high quality analytical test methods and validation reports meeting global regulatory requirements;
Demonstrated and/or group leader experience is preferred.
Location Westport, Co Mayo
Category Manufacturing / Engineering, Pharmaceutical / Science.
Last updated 21/03/2007
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