Job Description
CMC Manager North Leinster
Our client is young ambitious pharmaceutical company with a strong record of success in drug development. The newly appointed CMC Manager will report to the Head of Pharmaceutical Development and Pharmaceutical Technology. The person appointed will support pharmaceutical development projects to ensure the development of robust pharmaceutical products. They will support pharmaceutical technology projects and provide technical support to existing commercial products
KEY DUTIES AND RESPONSIBILITIES
Support the development and manufacture of pharmaceutical dosage forms and devices.
Support the development and validation of analytical methods for the testing of active ingredients, excipients, packaging materials, devices, drug products and drug product-device combination products.
Consistent with FDA standards, support the process validation of to-be commercial drug products. In addition, when changes have been made to the manufacture of commercial drug products, support the re-validation of such products.
Support the technical transfer of commercial manufacturing and analytical testing of drug products.
Support the preparation of regulatory filings such as INDs, ANDAs, NDAs and supplements
Stay current with emerging technology and regulatory guidance within industry.
Ensure effective partnership with other areas in the Company including Operations, Quality, Regulatory, Clinical and Pharmacovigilance.
Support the preparation of the Pharmaceutical Development & Pharmaceutical Technology budget.
Represent Pharmaceutical Development & Pharmaceutical Technology in internal and external (vendor) meetings and teleconferences in a positive, collaborative manner.
Contribute to the review of company policies and procedures.
Undertake any other duties, which may be assigned by Senior Management.
Gerry Kennedy, Managing Director, Recruitment for Technology Ltd.
Maple House, South County Business Park, Leopardstown, Dublin D18 F863