SK pharmteco (SK Inc) is a global Contract Development and Manufacturing organization (CDMO) with state-of-the-art small molecule manufacturing facilities in Korea, US, and Ireland.
Current Need
SK pharmteco Ireland is seeking a highly experienced Process Development Specialist in small molecule API to lead the development, optimisation, and scale-up of robust, safe, and cost-effective API processes from clinical through commercial stages.
Candidate Requirements
Critical thinker with deep technical knowledge of organic chemistry, process development, and purification strategies.
Proven experience in developing, optimising and scaling robust API processes from laboratory to manufacturing plant.
Innovator with strong technical experience in new technologies; able to drive continuous improvement and innovation in a high-growth, customer-centric organization.
Effective communicator, able to mentor, organise, mobilise and influence process development teams within the group.
Committed to excellence with a willingness to take ownership of process development activities.
The successful candidate will collaborate closely with Process R&D chemists, Technology Transfer functions, Quality (QA/QC), SHE, Process Engineering, Manufacturing and external stakeholders/customers to ensure flawless, compliant, first-time development and manufacture of APIs.
Key Responsibilities
Lead end-to-end development of API processes from the development laboratory through scale-up in the kilo-pilot laboratory and into GMP manufacturing for client programs across clinical and commercial phases.
Design and execute laboratory experiments to improve process robustness, yield, purity, and sustainability.
Collaborate effectively with R&D, technology transfer, and manufacturing teams to transfer API processes into GMP-compliant production environments.
Develop a detailed knowledge of production equipment within the manufacturing plant and work collaboratively with process engineers to ensure processes are appropriately modelled for effective scaling.
Apply Quality by Design (QbD) principles and statistical tools, including DoE, risk assessment, and multivariate analysis, to develop robust, scalable, and compliant processes, and to support the development of intermediate and API specifications and the identification of critical process parameters.
Perform risk assessments to proactively identify and mitigate potential scale-up or safety issues, including thermal hazards and exothermic reactions.
Provide technical leadership on process development projects, mentoring process development chemists within the team, and authoring and reviewing technical documentation such as process development reports, robustness documentation, and quality risk assessments.
Support the development of new project proposals, providing technical expertise to clients and internal teams to craft innovative solutions to complex multi-step processes.
Champion new technologies (PAT, automation, AI data tools, sustainability, etc.), creating business cases and leading their implementation to enhance the technical offering of the group.
Identify and troubleshoot technical issues during transfer, scale-up, and manufacturing campaigns; support investigations relating to process robustness and implement robust CAPAs using standard and statistical tools.
Lead cost-reduction projects, applying lean tools and techniques to improve processing efficiency such as throughput time, cost of goods, and yields.
Maintain compliance with data management systems (e.g., electronic lab notebooks) and cGMP, EH&S, and quality system requirements.
Support the management and effective running of R&D laboratories by promoting workflow efficiency, best practices, and a strong culture of safety across the team.
Qualifications: Education & Experience
PhD in Organic Chemistry or closely related field.
8-12 years of relevant experience in process development of small molecule APIs (CDMO experience strongly preferred).
Key Skills & Attributes
Motivated problem solver with strong technical expertise in organic synthesis and process development.
Critical thinker able to apply fundamental principles and innovative data-driven approaches to complex technical problems.
Experienced in the CDMO environment with comprehensive understanding of regulatory and quality requirements in GMP manufacturing.
Effective communicator and collaborator, with proven ability to build strong partnerships with internal teams and external clients, and to mentor and coach colleagues.
Skilled at managing client expectations and translating complex technical progress into concise updates.
Proficient in lab software, including electronic lab notebooks (ELNs) and data management systems; highly proficient in analytical methods and data interpretation to inform project decisions.
Collaborative mindset with ownership drive and ability to thrive in a dynamic, client-driven environment.
Other Benefits
Excellent opportunities for career enhancement and personal development.
Competitive base salary.
Annual bonus linked to business results.
Well-established further education program.
Pension scheme.
Private healthcare.
SK pharmteco SM Europe is an equal opportunity employer.
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