Helsinn is a privately-owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland, USA and China. Founded in 1976, the company has become known worldwide for its unique business model focused on the licensing of innovative pharmaceuticals, medical devices and nutritional supplement products in therapeutic niche areas. The Group in-licenses early to late stage new chemical entities, completes their development from the performance of pre-clinical/clinical studies and Chemistry, Manufacturing and Control (CMC), development to the filing for and attainment of their market approval worldwide. Helsinn’s products are out-licensed to its network of local marketing and commercial partners worldwide, selected for their deep in-market knowledge and know-how, and assisted and supported with a full range of product and scientific management services, including commercial, regulatory, financial, legal and medical marketing advice. The active pharmaceutical ingredients and the finished dosage forms are manufactured at Helsinn’s cGMP facilities in Switzerland and Ireland, and supplied worldwide to its customers.
Today Helsinn is committed to advancing quality patient care through the development and commercialization of cancer supportive care treatments to benefit both patients and caregivers. Helsinn focuses R&D investments and resources on enhancing cancer supportive care, a still underserved yet important therapeutic area.
A modern Group focused on growth and development but also tied to tradition and on the values of a family business: in Helsinn more than 500 employees work not only for the health of the patient, but overall for the quality of life of the person.
Ireland is a global center for pharmaceuticals manufacturing and supply for the top pharmaceutical companies worldwide with an excellent reputation for GMP compliance.
Since 1997 Helsinn Birex Pharmaceuticals has operated from a new state of art finished dosage facility in Damastown, Dublin, Ireland. From here Helsinn supplies its partners globally with ready to sell products on an exclusive basis, which are manufactured on site and/or using a netwowrk of high quality external manufacturing partners (CMO’s) located around the world.
In 2009 the Helsinn Group invested over EUR 13 million, with the support of the Irish Development Authority (IDA), to build a Centre-of-Excellence for oral solid dosage forms and Stability centre focused on developing the group pipeline of new solid dose products.
In 2011, further investments were made to increase the analytical testing capacity on the site. Helsinn has invested more than CHF50 million in Dublin and in dedicated capacity at the sites of its strategic contract manufacturing partners to guarantee all elements of the supply chain for development and commercial products.
Helsinn Birex offers interesting and challenging careers in a team based workplace with modern facilities and opportunities for advancement.
The primary purpose of the CMO Coordinator is to coordinate all aspects of CMO relationships and to ensure the optimum performance of our network of CMOs with respect to the quality of product supplied and the reliability of their production.
The primary purpose of the QAI is to sample all raw materials and intermediates received at HBP and to submit these samples to the QC Laboratory, to sample and test all packaging materials received at HBP and to perform a final check on all finished products prior to shipment
The primary purpose of the Computer System Validation Specialist is to plan, organise, lead and control all Quality Assurance Validation activities related to the introduction, validation and maintenance of site equipment