Process Development Specialist New
4 weeks ago
Process Development Specialist – Small Molecule API
Location: Swords, Co. Dublin
Contract Type: Permanent
About SK pharmteco
At SK pharmteco, part of SK Inc, we are a global Contract Development and Manufacturing Organization (CDMO) with world-class facilities in Korea, the US, and Ireland.
Our Small Molecule Europe facility in Swords, Co. Dublin has been a leader for over 60 years in the development, scale-up, and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates.
With exceptional technical capabilities, a talented workforce, and a culture of innovation, we produce some of the world’s most important medicines.
? Learn more: www.skpharmteco.com
The Opportunity
We are seeking a highly skilled and motivated Process Development Specialist to join our dynamic CDMO environment.
In this technical leadership role, you will lead the development, optimization, and scale-up of robust, safe, and cost-effective small molecule API processes from clinical to commercial manufacturing.
You will collaborate closely with R&D, Technology Transfer, Quality, SHE, Process Engineering, Manufacturing, and external clients to ensure right-first-time delivery of projects.
Key Responsibilities
- Lead end-to-end API process development from lab to GMP manufacturing.
- Design and execute experiments to improve process robustness, yield, purity, and sustainability.
- Apply Quality by Design (QbD) and statistical tools such as DoE, risk assessment, and multivariate analysis.
- Identify and mitigate potential scale-up or safety risks, including thermal and exothermic hazards.
- Provide technical leadership and mentor development chemists.
- Author and review technical and quality documentation.
- Support new project proposals and contribute to client technical discussions.
- Champion and implement new technologies (PAT, automation, AI tools, sustainability).
- Lead cost reduction and process efficiency initiatives.
- Ensure full compliance with cGMP, EH&S, and electronic lab notebook systems.
- Foster a culture of safety, collaboration, and technical excellence.
Qualifications
- PhD in DoE or a closely related field.
- 8–12 years’ experience in small molecule API process development (CDMO experience preferred).
Key Skills & Attributes
- Deep technical expertise in organic synthesis and process development.
- Strong analytical and problem-solving mindset.
- Proven track record in GMP and regulatory environments.
- Excellent communication and collaboration skills with internal and external stakeholders.
- Experience mentoring team members and managing client relationships.
- Proficiency in ELNs and data management systems.
- Proactive, innovative, and results-driven attitude.
What We Offer
- Excellent opportunities for career growth and professional development.
- Competitive salary and annual bonus linked to company performance.
- Private healthcare, pension scheme, and education support programs.
- A collaborative, innovation-driven culture where your ideas matter.
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