High Potency API (HPAPI) Specialist
CPL in partnership with our client SK biotek are seeking a High Potency API (HPAPI)specialist to join the team for a permanent contract based at Swords.
SK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France, and Ireland. We are part of the wider SK Inc. with revenues of $88 billion in 2022. Our mission is to ‘make what matters for a healthy, happier world,’ from grams to tonnes. 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. With a talented workforce, exceptional technical capabilities, and facilities we have made some of the world’s most important medicines and continue to do so. Further information on SK pharmteco can be found at https://vimeo.com/skpharmteco.
Current Need:
SK biotek Ireland are seeking to recruit a specialist in HPAPI on a permanent basis. This position is based at the R&D Department in Swords, Co Dublin. The R&D Department has co-located technical and operational expertise, including analytical expertise that supports the development and manufacture of clinical and commercial products (small molecule APIs) including highly potent APIs with OELs less than 1ug. /m3 and lower.
Position Description:
The HPAPI specialist will require in-depth knowledge and expertise in the safe handling and development of HPAPI products. The HPAPI specialist will use their experience in synthetic organic chemistry to support all aspects of new and existing chemical processes for Highly potent APIs on site. This will include new product introductions from customers, process development, process safety, process monitoring and troubleshooting, scale up and transfer to GMP kilo lab or plant. The role will involve cross-functional collaboration with our Operations, Project Management, Quality and SHE groups as well as with our customers. The R&D department at SK biotek Ireland are a customer focused group supporting projects from early clinical phases all the way through to commercial production.
As part of your role in these activities, you will:
- Work with a team of R&D chemists to lead development projects in the High containment laboratory. This may include route scouting and development, completion of proof-of-concept studies, crystallisation optimisation, and process safety assessments as required.
- 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 R&D project leads, project management group, and other functions such as SHE, Operations and Quality to ensure that project milestones on HPAPI projects are delivered as per the project plan.
- Work cross-functionally to ensure that project documentation and campaign readiness activities are completed on time.
- 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.
- Key member of the high potency audit team
- Assist in the preparation of Request for information and process RFI/RFPs for new product introductions (NPIs).
- Work with our customers on development projects to ensure that the final process taken to the manufacturing plant is understood, robust, efficient, in-control and meets their expectations.
- Act as product lead for specific API product(s), providing technical support for their manufacture.
- Lead optimization projects on throughput and yield in collaboration with Operations engineers.
- Actively participate in cross functional manufacturing campaign performance support teams and project teams for equipment.
- Actively participate in cross functional project teams for equipment and laboratory upgrades.
- Lead and support quality and safety investigations as required.
- Additionally, you will take an active role in the delivery of R&D metrics for safety and quality across all processes and activities operating on site.
Minimum 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
- Technical know-how on development of Antibody Drug Conjugates (ADC) linker payload complex APIs or Hi-potency APIs (HPAPIs).
- Significant Experience in the manufacture or development of linker payloads.
- Subject matter expert on the scale up of Chromatography, freeze drying, nano filtration and Tangential flow filtration.
- Significant experience in the use of Glove boxes and flexible isolator.
- Strong interpersonal and communicational skills and demonstrated ability to work across a matrix.
- Excellent problem-solving skills and commitment to continuous improvement.
- Ensuring that GMP, Quality, Health & Safety are considered in all aspects of the role.
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.
Other Benefits include:
- Excellent opportunities for career enhancement and personal development
- Competitive base salary
- Annual bonus linked to business results.
- A well-established further education program.
- Pension scheme
- Private Healthcare