Principal Scientist API Process Development

Job description

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

Current Need: We are seeking a highly skilled and motivated Principal Scientist / Chemist to join our Process Development team within a dynamic CDMO environment.

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.

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.

Education: Ph.D. in Organic Chemistry, Chemical Engineering, or a related discipline.

M.Sc. with significant industry experience will also be considered.

Experience: 812+ 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.

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

Required Skill Profession

Life Scientists