Process Development Specialist – Small Molecule API

Cpl Group View all jobs

  • Dublin
  • Permanent
  • Full-time
  • 24 days ago
Cpl in partnership with SK pharmteco are hiring a permanent Process Development Specialist - Small Molecule API to join the team in Swords campus, North Dublin.About SK pharmtecoAt 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.The OpportunityWe 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 Organic Chemistry or 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.
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