Principal Scientist
API Process Development
Location: Swords
About the company
SK pharmteco, part of SK Inc, is a global Contract Development and Manufacturing organisation (CDMO) with state-of the-art small molecule manufacturing facilities in Korea, US, and Ireland. The SK Small Molecule Europe facility located in Swords, Co Dublin, Ireland has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 60 years. With a talented workforce, exceptional technical capabilities and facilities we make some of the world’s most important medicines. Further information on SK pharmteco can be found at www.skpharmteco.com
Current Need:
SK pharmteco Ireland are seeking to recruit a highly experienced Principal Scientist to lead a team in the process R&D group.
We are seeking a highly skilled and motivated Principal Scientist / Chemist to join our Process Development team within a dynamic CDMO environment. The successful candidate will lead the development, optimization, and scale-up of robust, safe, and cost-effective chemical processes for the manufacture of Active Pharmaceutical Ingredients (APIs) and intermediates, from clinical through commercial stages.
This is a senior-level role that demands both technical expertise and leadership capabilities, with opportunities to mentor junior scientists and interface directly with clients and cross-functional teams.
As a Principal Scientist in API Process Development at our SK Pharmteco site you will play a key leadership role in delivering high-quality, innovative solutions for our global clients. This role combines deep expertise in API process development with a passion for adopting cutting-edge technologies to drive efficiency, quality, and scalability across diverse development programs.
You will be responsible for leading the design, development, and scale-up of chemical processes for small-molecule APIs, while evaluating and implementing new manufacturing technologies such as continuous flow processing, process analytical technologies (PAT), and digital process optimization tools.
You will act as both a technical expert and a client-facing scientific leader, helping ensure successful development, technology transfer, and GMP manufacturing within tight timelines and regulatory frameworks.
Primary Responsibilities:
- Lead end-to-end development of API processes from route scouting through scale-up and GMP manufacturing for client programs across clinical and commercial phases.
- Collaborate with clients and internal stakeholders to define development strategies, technology selection, timelines, and deliverables.
- Evaluate and implement innovative process technologies to improve yield, robustness, scalability, sustainability, or cost-efficiency, including the following non exhaustive list:
- Continuous flow chemistry
- Crystallisation Development
- Advanced automation and real-time data analytics
- PAT tools and real-time release testing
- Green chemistry principles and solvent reduction
- Contribution to successful technology transfer into the site from clients or partner organizations, and from development to manufacturing.
- Serve as the scientific lead in troubleshooting process issues during familiarization, optimisation and scale up, ensuring rapid and compliant resolution.
- Perform risk assessments, identify and mitigate potential scale-up or safety issues (e.g., thermal hazards, exothermic reactions).
- Develop and implement Design of Experiments (DoE) to optimize critical process parameters.
- Collaborate closely with internal cross-functional teams including Analytical, Quality Assurance, Tech. transfer, Manufacturing, Engineering, Supply chain and SHE.
- Author and review technical documentation, including process development reports, risk assessments, and CMC regulatory submissions.
- Stay current with emerging trends and technologies in chemical process development and apply them strategically to enhance client offerings.
- Mentor and develop scientists within PR&D and contribute to a culture of innovation and continuous improvement.
Qualifications:
Education:
- Ph.D. in Organic Chemistry, Chemical Engineering, or a related discipline.
- M.Sc. with significant industry experience will also be considered.
Experience:
- 8–12+ years of relevant experience in pharmaceutical API process development, preferably in a CDMO or fast-paced multi-client environment.
- Proven track record in process scale-up, technology transfer and GMP manufacturing.
- Strong understanding of CDMO operations, client engagement, and regulatory expectations (e.g., IND, IMPD, NDA, MAA submissions).
- Strong technical experience in new technologies (flow chemistry, PAT, automation, etc. and leadership in implementing new technology projects.
- >5 years’ experience leading teams in the delivery of complex process development projects.
Key Skills & Attributes:
- Strategic scientific and technical leadership across diverse projects and molecules.
- Effective communicator with a track record of building strong partnerships with internal stakeholders and external clients.
- Experience managing client expectations and highly skilled at translating complex technical progress into concise updates.
- Deep knowledge of synthetic organic chemistry or chemical engineering principles applied to scalable API manufacturing.
- Experience applying QbD and risk assessment tools as part of process development to meet regulatory expectations.
- A strong collaborative mindset with a willingness to take ownership and ability to thrive in a dynamic, client-driven environment.
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