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Principal scientist - api process development

Dublin
Cpl Resources
Principal scientist
€80,000 - €100,000 a year
Posted: 9h ago
Offer 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:
o Continuous flow chemistry
o Crystallisation Development
o Advanced automation and real-time data analytics
o PAT tools and real-time release testing
o 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:

* 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.


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

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