Process Development Senior Scientist - Drug Product Technologies

Join 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 Do In this vital role you will join the Pre‑Pivotal Drug Product Technologies group, responsible for early‑stage drug product development across diverse modalities, with a strong emphasis on antibody‑drug conjugates (ADCs), as well as monoclonal antibodies, multispecifics and other biologic modalities. The role involves designing and developing liquid and lyophilized formulations; evaluating critical quality attributes (CQAs); establishing robust, scalable fill/finish processes for complex biologic drug products; and authoring and supporting high‑quality regulatory submissions. The ideal candidate will bring hands‑on experience in ADC drug product formulation and drug product process development, including a mechanistic understanding of linker‑payload attributes, stability/process‑relevant degradation pathways, and analytical strategies used to characterize ADC CQAs. You will integrate formulation, analytical, and process data to guide product design, apply cutting‑edge technologies (including AI/ML), and collaborate cross‑functionally to deliver high‑quality, stable, and manufacturable drug products for clinical development in a fast‑paced environment. Key Responsibilities Work effectively in a fast‑paced, matrixed environment, collaborating across process development, research, regulatory, and manufacturing teams to advance programs and communicate technical recommendations to both scientific peers and leadership. Plan and execute formulation and fill/finish process studies for early‑stage programs. Develop and characterize liquid and lyophilized formulations for biologics, with particular emphasis on ADC drug product formulation, handling, and lab‑scale sterile filling. Build process understanding across unit operations to support scalable drug product development. Evaluate in‑use compatibility and drug product stability under clinical conditions. Investigate ADC‑ and biologics‑relevant CQAs to inform formulation and process design decisions. Leverage high‑throughput tools for formulation screening and processability assessments. Identify and address technology gaps impacting ADC stability, linker‑payload integrity, protein‑excipient interactions, and process‑related stress responses. Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision‑making. Ensure development approaches are phase‑appropriate, from discovery through clinical manufacturing. Author technical documents, control‑strategy inputs, risk assessments, IND/CTA regulatory sections, and tech 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. Present findings to internal/external stakeholders and participate in cross‑functional teams. What We Expect Of You The Scientific professional we seek is an individual with these qualifications. Basic Qualifications Doctorate degree PhD OR PharmD OR MD [and relevant post‑doc where applicable] OR Master’s degree and 3 years of Scientific experience OR Bachelor’s degree and 5 years of Scientific experience Preferred Qualifications PhD in Pharmaceutics, Biotechnology, Biochemistry, or related field with 2–4 years of post‑doc or industry experience. Proven experience in formulation development, stability testing, and fill/finish operations for biologics; direct ADC drug product formulation experience is strongly preferred. Demonstrated understanding of ADC drug product development considerations, including linker‑payload stability, drug‑to‑antibody ratio, free drug or payload degradation, quality attributes, and product/process comparability. Experience integrating formulation, stability, and analytical data to advance ADC candidates from discovery or preclinical development into clinical manufacturing is highly desirable. Strong foundation in analytical and biophysical techniques relevant to ADCs and biologics. Familiarity with clinical‑stage development, manufacturability, and risk‑based decision‑making. Experience applying AI/ML to streamline R&D and optimize performance. Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs). What You Can Expect Of Us We support your professional and personal growth and well‑being with a competitive benefits package and collaborative culture. A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program. Stock‑based long‑term incentives. Award‑winning time‑off plans. Flexible work models where possible. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr Amgen