Process Development Specialist

Job description

SK pharmteco Ireland are seeking to recruit a highly experienced Process Development Specialist in small molecule API.

We are seeking a highly skilled and motivated Process Development Specialist to join a dynamic CDMO environment in the scale-up and production of small molecule Active Pharmaceutical Ingredients (APIs).

The successful candidate will lead the development, optimization, and scale-up of robust, safe, and cost-effective API processes for the manufacture of Active Pharmaceutical Ingredients (APIs) and intermediates, from clinical through commercial stages.

This technical leadership role demands in-depth knowledge of organic chemistry, process development, purification, and cGMP manufacturing practices.

The successful candidate must:

• Be a critical thinker, with a deep technical knowledge of organic chemistry, process development, purification strategies.

• Have proven experience in the development, optimisation and scaling of robust, sustainable API processes from the laboratory to the manufacturing plant.

• Be an innovator with strong technical experience in new technologies.

Able to drive continuous improvement and innovation in a high-growth, customer-centric organization.

• Be an effective communicator, able to mentor, organize, mobilise and influence process development teams within the group.

• Be committed to excellence in their work, with a willingness to take ownership of process development activities.

The successful candidate will collaborate closely with several stakeholders, including Process R&D chemists, Technology Transfer functions, Quality (QA/QC), SHE, Process Engineering, Manufacturing and external stakeholders/customers working towards the flawless, compliant and right 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.

Work collaboratively with process engineers to ensure processes are appropriately modelled to support 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.

Use these tools to support the development of intermediate and API specification 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.

Author and review technical documentation, including process development reports, process robustness documentation and quality risk assessments.

• Support the development of new project proposals, providing technical expertise to clients and internal teams to help craft innovative solutions to complex multi-step processes.

• Champion new technologies (PAT, automation, AI data tools, sustainability etc.), creating business cases for them 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 support the identification and implementation of robust CAPAs through application of 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 system, e.g. electronic lab notebooks and with cGMP, EH&S, and quality system requirements.

• Support the management and effective running of R&D laboratories by promoting workflow efficiency, best practices, and promoting a strong culture of safety across the team.

Qualifications: Education and Experience:

• PhD in Organic Chemistry or closely related field.

• 8-12 years of relevant experience in process development of small molecule APIs (CDMO experience is strongly preferred).

Key Skills & Attributes:

• A motivated problem solver who excels in a hands-on laboratory environment, bringing strong technical expertise in organic synthesis and process development to drive practical, innovative solutions.

• A critical thinker, able to understand, rationalise and identify solutions to complex technical problems by applying fundamental principles and innovative data-driven approaches.

• Experienced in the CDMO environment with a broad understanding of regulatory and quality requirements in GMP manufacturing, including familiarity with regulatory documentation and process validation.

Required Skill Profession

Business Operations Specialists