Role Summary 

This role will require the candidate to provide support to Capital expansion projects within the scope of the Process development function, contribute with subject matter expertise for Formulation unit operations, and long-term commercial support to Drug product manufacturing. 

The candidate will provide technical support to drug product formulation manufacturing 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 support for process performance, technical troubleshooting, process improvement strategies, process validation activities, investigations, and cross-functional technical communication.

Key Responsibilities 

New Product Introduction, Lifecycle Management & SME Support 

• Assist in the development and characterization of drug product processes and support technology transfer to commercial 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-use systems, 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, formulation and transportation for parenteral products through the NPI and post-NPI phases. 

• Provide Process Development expertise for commercial drug product processing in areas such as Single 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 where required. 

Process Validation, Risk Assessment & Compliance 

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

• Ensure that all activities within any process validation /characterisations adhere to required policies and procedures, including safety and training requirements. 

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

• Participate in process validation cross-functional teams at the site to ensure adherence to required policies and procedures. 

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

• Collaborate with teams on risk assessments for drug product operations and propose or implement appropriate CAPA. 

Investigations, Forensic Lab Support & Continuous Improvement 

• Assist in deviation and exception resolution, root cause analysis, and investigation closure. 

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

• Provide support to the PD forensic lab and act as a link to Manufacturing on key investigations as a process expert. 

• Identify and 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 teams across ADL and the Amgen 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 manufacturing objectives. 

Basic Qualifications 

• Third-level Bachelor’s degree in Science, Engineering, or a relevant Quality discipline with 2-3 years’ experience in a similar role; or Master’s degree with 2 years of directly related experience; or Associate’s degree with 5 years of directly related experience. 

• Knowledge of cGMPs and other worldwide regulatory requirements. 

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

Preferred Qualifications 

• PhD or Master’s degree in Science, Engineering, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, or a related discipline. 

• 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, filtration and mixing 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.