About Us
Skyepharma company, a global Contract Development and Manufacturing organisation (CDMO), operates state-of-the-art facilities in Korea, US, France, and Ireland. As part of SK Inc., we generate $88 billion in revenue each year. Our mission is to create products that enhance people's lives and make the world a healthier, happier place.
The Swords Campus has been at the forefront of Active Pharmaceutical Ingredient (API) development, scale-up, and commercial manufacture for nearly 60 years. We are seeking an expert in HPAPI on a permanent basis to join our team in Ireland.
Position Description:
The High Potency API Specialist will require extensive knowledge and experience in safely handling and developing HPAPI products. This role involves applying synthetic organic chemistry expertise to support all aspects of new and existing chemical processes for Highly potent APIs on site. Key responsibilities include supporting customers with new product introductions, process development, process safety, process monitoring, and troubleshooting. The specialist will work closely with Operations, Project Management, Quality, and SHE groups to ensure successful project outcomes.
Duties:
* Collaborate with R&D chemists to lead development projects in the High Containment Laboratory.
* Develop routes for synthesis, complete proof-of-concept studies, crystallisation optimisation, and process safety assessments as required.
* Identify and implement new technologies to support business needs.
* Cross-functional collaboration to ensure laboratory operations can be implemented successfully in the manufacturing plant.
* Work with analytical R&D chemists to ensure updated procedures have appropriate methods in place.
* Coordinate with R&D project leads, project management, and other functions to deliver project milestones on HPAPI projects.
* Assist in preparing Request for Information (RFI) and Requests for Proposal (RFP) for new product introductions.
* Provide technical support for customer development projects.
Key Requirements:
* Technical knowledge of complex APIs or Hi-potency APIs (HPAPIs).
* Familiarity with HPAPI handling systems, containment equipment, facility design, personnel training, and PPE.
* Experience in a GMP kilo lab in the pharmaceutical industry for 5+ years.
* PhD in Organic Chemistry or Chemical Engineering with 5+ years practical lab experience.
* Knowledge of Antibody Drug Conjugates (ADC) linker payload complex APIs or Hi-potency APIs (HPAPIs).
Benefits:
* Opportunities for career advancement and personal development.
* Competitive base salary.
* Annual bonus linked to business results.
* A well-established further education program.
* Pension scheme.
* Private Healthcare.