Process Development Senior Scientist – Drug Product Technologies

Job description

Career CategoryOperationsJob DescriptionJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Senior Scientist – Drug Product Technologies What you will doLet’s do this. Let’s change the world. In this vital role you will bring hands-on experience in biologics drug product formulation, process development, and/or analytical characterization, with experience in ADCs and/or oligonucleotides such as siRNAs strongly preferred. The candidate will integrate formulation, analytical, stability, and process data to guide product design and development, including modality-specific considerations such as linker-payload attributes, stability- and process-relevant degradation pathways, ADC CQAs, oligonucleotide formulation and stability considerations, and phase-appropriate analytical strategies. This individual will apply scientific judgment, emerging technologies including AI/ML, and strong cross-functional collaboration to deliver high-quality, stable, and manufacturable drug products for clinical development in a fast-paced environment. Work effectively in a fast-paced, matrixed environment, collaborating across process development, research, analytical, regulatory, quality, manufacturing, and external partner teams to advance programs, influence development strategies, and communicate technical recommendations to scientific peers and leadership. Plan, lead, and execute formulation, stability, process development, and fill/finish studies for early-stage drug product programs across diverse biologic modalities. Develop and characterize liquid and lyophilized formulations for complex biologics, including ADCs, oligonucleotides, monoclonal antibodies, multispecifics, and other emerging modalities. Build process understanding across unit operations to support scalable drug product development. Evaluate in-use compatibility and drug product stability under clinically relevant conditions. Investigate biologics- and modality-relevant CQAs, including aggregation, fragmentation, charge and size variants, subvisible particles, surface interactions, concentration-dependent behavior, and, where applicable, ADC- or oligonucleotide-specific attributes such as drug-to-antibody ratio, free payload, linker-payload integrity, and oligonucleotide purity or degradation pathways. Leverage high-throughput and data-driven tools for formulation screening, stability assessment, developability evaluation, and processability characterization. Identify and address technology gaps impacting drug product stability, manufacturability, excipient interactions, modality-specific degradation pathways, and process-related stress responses. Apply machine learning, AI, automation, and data science approaches to predictive modeling, workflow acceleration, data integration, and decision-making. Ensure development approaches are phase-appropriate, from discovery through clinical manufacturing. Provide scientific and technical leadership in biologics drug product development, serving as a subject matter expert for formulation, stability, process development, and modality-specific considerations for ADCs, oligonucleotides, and other complex biologics. Define and influence drug product development strategies across programs by identifying key risks, recommending phase-appropriate studies, and integrating formulation, analytical, process, manufacturability, and regulatory considerations into program decisions. Serve as a recognized scientific resource within area of expertise, providing technical guidance, mentorship, and coaching to junior scientists and cross-functional team members. Author and review technical documents, formulation and process development reports, control-strategy inputs, risk assessments, IND/CTA regulatory sections, and technology transfer packages. Support internal and external technology transfer activities, including collaboration with CMOs/CDMOs, batch record review, process fit assessments, person-in-plant support, and troubleshooting during manufacturing campaigns. What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 2 years of Scientific experience OR Bachelor’s degree and 4 years of Scientific experience Preferred Qualifications: PhD in Pharmaceutics, Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field with 3+ years of relevant industry experience. Proven experience in biologics drug product formulation development, stability assessment, process development, and/or fill/finish operations; direct experience with ADCs, oligonucleotides such as siRNAs, or other complex biologic modalities is strongly preferred. Demonstrated understanding of drug product development considerations for biologics and complex modalities, including formulation stability, degradation pathways, aggregation, particulates, manufacturability, product/process comparability, and phase-appropriate control strategies. Experience with ADC drug product development considerations, including linker-payload stability, drug-to-antibody ratio, free drug or payload-related impurities, ADC-relevant quality attributes, and process-related stress responses, is highly desirable. Experience with oligonucleotide or siRNA drug product development considerations, including formulation stability, degradation pathways, excipient compatibility, analytical characterization, and clinical administration considerations, is highly desirable. Experience integrating formulation, stability, analytical, and process data to advance drug product candidates from discovery or preclinical development into clinical manufacturing. Strong foundation in analytical and biophysical techniques relevant to biologics, ADCs, and/or oligonucleotides, such as UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, LC-MS, subvisible particle analysis, viscosity, osmolality, and stability-indicating methods. Familiarity with clinical-stage development, manufacturability, technology transfer, and risk-based decision-making. Experience applying AI/ML, automation, LLMs, in silico tools, or data science approaches to streamline R&D workflows, improve data integration, and support decision-making. Skilled communicator with experience authoring technical reports and contributing to regulatory submissions, including INDs, CTAs, BLAs, or equivalent global filings. What you can expect from usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several fa