Process Development Specialist

1 week ago

Dublin, Ireland Cpl Full time

Process Development Specialist – Small Molecule APILocation: 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: 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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