Sr. Associate Process Development

• 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.

• 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   system s, 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.

• 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 .

• S upport 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.

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

• 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.

• 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 .

• 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.

• 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.

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