Sr. Associate Process Development (Biotechnology)

Location: Dun Laoghaire, Ireland

Salary: EUR 59,569.70–80,594.30 per year

Company

hirify.global develops and manufactures medicines, including large-molecule and small-molecule drug products.

What you will do

• Support formulation process development, characterization, technology transfer, and lifecycle management for drug products.
• Qualify and implement formulation technologies, including mixing systems, filtration technologies, single-use systems, and critical manufacturing equipment.
• Provide technical input to the design, commissioning, qualification, validation, and start-up of new formulation facilities.
• Support manufacturing operations through troubleshooting, engineering runs, characterization studies, process performance qualification, investigations, and process improvement.
• Prepare technical protocols, reports, assessments, investigation summaries, and technical updates for cross-functional and governance forums.
• Collaborate with Operations, Engineering, Quality, Validation, Supply Chain, Regulatory Affairs, Global Process Development, and external vendors.

Requirements

• Bachelor’s degree in Science, Engineering, or a relevant Quality discipline with 2–3 years of similar experience; alternatively, a Master’s degree with 2 years of directly related experience or an Associate’s degree with 5 years of directly related experience.
• Knowledge of cGMPs and worldwide regulatory requirements, including FDA and EU standards.
• Experience or knowledge in sterile processing, formulation process characterization, technology transfer, process validation, and commercial drug product manufacturing.
• Ability to apply scientific and engineering principles to protein freeze-thawing, filtration, and mixing processes.
• Knowledge of quality systems, deviation management, CAPA, risk assessment, and drug product manufacturing.
• Strong problem-solving, communication, cross-functional collaboration, and technical presentation skills.

Nice to have

• PhD or Master’s degree in Science, Engineering, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, or a related discipline.
• Experience with protein biochemistry and chemical and physical stability considerations.
• Experience supporting vial and syringe filling process performance qualifications.

Culture & Benefits

• Work as part of a global Process Development organization supporting site expansion and commercial manufacturing.
• Collaborate across technical, manufacturing, quality, engineering, validation, regulatory, and supply chain functions.
• Participate in technical governance forums and communicate with site leadership and senior stakeholders.
• Support GMP-regulated manufacturing activities and applicable international quality and safety requirements.