High Potency API (HPAPI) Specialist
SK pharmteco, a global Contract Development and Manufacturing organisation (CDMO), is seeking a High Potency API (HPAPI) specialist to join our team for a permanent contract based at Swords.
We are part of the wider SK Inc. with revenues of $88 billion. Our mission is to 'make what matters for a healthy, happier world.' The Swords Campus has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs), Highly Potent Active Pharmaceutical Ingredients (HPAPI) and Chemical Intermediates for almost 60 years.
Position Overview:
The HPAPI specialist will require in-depth knowledge and expertise in the safe handling and development of HPAPI products. The role will involve cross-functional collaboration with our Operations, Project Management, Quality and SHE groups as well as with our customers.
Key Responsibilities:
- Lead development projects in the High containment laboratory, including route scouting and development, proof-of-concept studies, crystallisation optimisation, and process safety assessments.
- Identify and implement new technologies to support development for the business needs of the site.
- Collaborate with Operations engineers to ensure that process development operations demonstrated in the laboratory can be implemented successfully in the manufacturing plant and with analytical R&D chemists to ensure that appropriate methods are in place for updated procedures.
- Collaborate with project engineering and R&D team to manufacture batches in the GMP kilo lab facility and bring new technology on site.
- Work with SHE to ensure that our containment practices in R&D and in high potency handling plant areas are continuously improving and benchmarked and meet Industry standards and expectations.
- Assist in the preparation of Request for information and process RFI/RFPs for new product introductions (NPIs).
- Act as product lead for specific API product(s), providing technical support for their manufacture.
Requirements:
- Technical know-how on handling of complex APIs or Hi-potency APIs (HPAPIs).
- Know-how of Hi-potent (HPAPI) handling systems starting with process isolation, to the use of the proper containment equipment, to the overall facility design, to personnel training, and finally PPE.
- Experience in a GMP kilo lab in the pharmaceutical industry of 5 years or more.
- PhD in organic chemistry or chemical engineering of 5 years practical lab experience
Additional Skills Relevant to the Role:
- Experience in project management, troubleshooting and equipment installation.
- Demonstrated capability in the use of standard tools for root cause analysis and standard statistical tools.
Why Choose a Career at SK pharmteco?
A career with purpose and a chance to work with a world-leader in contract development and manufacturing in a fast-paced, dynamic, and growing organisation. By choosing a career with SK pharmteco, you will join a team of passionate people working together to improve lives by making what matters for a healthy, happier world.