Principal Scientist - API Process Development New

Cpl in partnership with SK pharmteco are looking to hire a permanent Principal Scientist for API Process Development onsite in the Swords Campus

ABOUT US?

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 on a permanent contract.

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

SK pharmteco SM Europe is an equal opportunity employer