Sr. Associate Process Development

Amgen; Dublin; On-site; EUR 60,000 - 81,000; Full time

Job summary

Amgen DunLaoghaire (ADL) seeks a Senior Associate to support process development for new formulation processes and technology transfer across major site expansions. You will contribute formulation characterization, qualification of technologies, and implementation of single-use systems for new formulation rooms.

The role covers process performance, troubleshooting, validation activities, CAPA and cross-functional communication within the global Process Development network.

Qualifications

• Bachelor’s or higher in Science/Engineering with 2–3 years in a similar role.
• Knowledge of cGMPs and global regulatory requirements.
• Strong problem-solving and excellent written and verbal communication.
• Experience with formulation process characterization and technology transfer.
• Preferred: PhD or Master’s with protein drug product processing experience.

Responsibilities

• New Product Introduction, Lifecycle Management & SME Support.
• Formulation Process Characterization & Technology Implementation.
• Manufacturing Support & Technical Troubleshooting.
• Process Validation, Risk Assessment & Compliance.
• Investigations, Forensic Lab Support & Continuous Improvement.
• Leadership, Communication & Cross-Functional Collaboration.

Skills

cGMP knowledge

Problem-solving

Communication skills

Cross-functional collaboration

Project management

Formulation processes

Education

Bachelor's degree in Science/Engineering

Master's degree in related field

PhD in a relevant discipline

Job description

Career Category

Scientific

Job Description

The Senior Associate will provide Process Development supportprimarilyto the new formulation processes being introduced in Amgen DunLaoghaire(ADL), formulation process characterization, qualification of formulation technologies, and implementation of new single-use technologies for new formulation rooms. The role will support large molecule and small molecule drug product manufacturing at ADL as part of the global Process Development organization.

Role Summary

This role will require the candidate to provide support toCapital expansion projectswithin thescope oftheProcessdevelopment function, contributewithsubject matterexpertisefor Formulation unit operations, and long-termcommercialsupporttoDrug productmanufacturing.

The candidate will provide technical support to drug productformulationmanufacturing at ADL and will contribute as part of the global Process Development organization.

The successful candidate will play a key role in supporting major site expansion initiatives, including formulation process characterization, qualification of formulation technologies, and implementation of new single-use technologies for new formulation rooms.

The role will include supportforprocess performance, technical troubleshooting, process improvement strategies,processvalidationactivities, investigations, and cross-functional technical communication.

Key Responsibilities

NewProduct Introduction, Lifecycle Management & SME Support

• Assistin the development and characterization of drug product processes and support technology transfer tocommercial drug product sites.

• Contribute to product quality assessments, process flow documents, technical assessments, and process control strategies.

Formulation Process Characterization & Technology Implementation

• Support formulation process characterization activities, including study design, protocol generation, execution support, data assessment, and technical report authoring.

• Support qualification and implementation of formulation technologies for new formulation rooms, including mixing systems, filtration technologies, single-usesystems, and other critical formulation equipment.

• Provide technical input into the design, qualification, and operational readiness of new formulation facilities and manufacturing capabilities.

• Support commissioning, qualification, validation, and start-up activities in partnership with Engineering, Validation, Operations, Quality, and external vendors.

• Apply scientific and engineering principles to formulation, freeze-thaw, filtration, mixing, processes for parenteral products.

Manufacturing Support & Technical Troubleshooting

• Act as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing,formulationand transportation for parenteral products through the NPI and post-NPI phases.

• Provide Process Developmentexpertisefor commercial drug product processing in areas such asSingle use systems,sterile processing, process characterization.

• Support commercial drug product manufacturing operations with technical evaluation of non-conformances, CAPA, and technology transfer activities.

• Interface with Manufacturing and support functions to provide robust, coordinated support to manufacturing operations.

• Troubleshoot issues with drug product processing technologies and equipment.

• Support Process Development activities on the manufacturing line such as engineering runs, characterization studies, and PPQs, including periods of shift support whererequired.

ProcessValidation, Risk Assessment & Compliance

• Support process performance qualifications (PPQs) for vial and syringe filling.

• Ensure that all activities within anyprocessvalidation/characterisationsadhere to required policies and procedures, including safety and training requirements.

• Ensure that the sitemeetscustomer quality requirements and applicable regulations, including FDA, EU, and international standards.

• Participate inprocessvalidationcross-functional teams at the site to ensure adherence to required policies and procedures.

• Collate and report on relevant shipping and filter validation activities.

• Collaboratewith teamsonrisk assessments for drug product operations and propose or implementappropriate CAPA.

Investigations, Forensic Lab Support & Continuous Improvement

• Assistin deviation and exception resolution, root cause analysis, andinvestigationclosure.

• Provide recommendations to management during investigations and support data-driven decision-making.

• Provide support to the PD forensic lab and act as a link toManufacturing onkey investigations as a process expert.

• Identifyand implement operational opportunities for current and new sterile operations.

• Support process performance monitoring and implementation of process improvement strategies.

• Participate in project activities and continue developing associated project management and cross-functional leadership skills.

Leadership, Communication & Cross-Functional Collaboration

• Communicate complex technical topics clearly and confidently to cross-functional teamsacrossADL and theAmgen network, technical governance forums, and site leadership.

• Prepare high-quality technical protocols, reports, assessments, investigation summaries, and executive-ready technical updates.

• Work collaboratively with Operations, Engineering, Quality, Validation, Supply Chain, Regulatory Affairs, Global Process Development, and external vendors.

• Influence without direct authority by providing clear technical rationale, risk-based recommendations, and practical implementation plans.

• Demonstrate ownership, accountability, and effective decision-making in support of site expansion, NPI, validation, and commercial manufacturingobjectives.

Basic Qualifications

• Third-levelBachelor’s degree in Science, Engineering, or a relevant Quality discipline with 2-3 years’ experience in a similar role; orMaster’sdegree with 2 years ofdirectly relatedexperience; orAssociate’sdegree with 5 years ofdirectly relatedexperience.

• Knowledge ofcGMPsand other worldwide regulatory requirements.

• Strong problem-solving ability and excellent oral and written communication skills.

Preferred Qualifications

• PhD orMaster’s degree in Science, Engineering, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, ora relateddiscipline.

• 2-3 years of experience supporting commercial protein drug product processing in areas such as sterile processing, process characterization, technology transfer to commercial drug product sites, or validation.

• Experience supporting formulation process characterization, qualification of formulation technologies, and implementation of new single-use technologies in a GMP manufacturing environment.

• Strong skills in applying fundamental engineering and scientific principles to design, implementation, and process validation of protein freeze-thawing,filtrationandmixing processes.

• Knowledge of protein biochemistry, including chemical and physical stability considerations.

• Knowledge of quality systems, drug product manufacturing, validation, deviation management, CAPA, and risk assessment methodologies.

• Demonstrated ability to work in cross-functional teams and advance complex projects to completion.

• Excellent communication skills, including the ability to present technical topics to senior stakeholders and non-technical audiences.

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Salary Range

59,569.70EUR-80,594.30EUR