Process Development Senior Scientist - Drug Product Technologies

Process Development Senior Scientist - Drug Product Technologies At Amgen, we are dedicated to serving patients living with serious illnesses. We are looking for a Senior Scientist to join our Pre‑Pivotal Drug Product Technologies group and help develop early‑stage drug products across diverse modalities, with a strong emphasis on antibody‑drug conjugates (ADCs), monoclonal antibodies, multispecifics, and other biologics. What You Will Do In this vital role you will design and develop liquid and lyophilized formulations; evaluate critical quality attributes (CQAs); establish robust, scalable fill/finish processes for complex biologic drug products; and support high‑quality regulatory submissions. You will bring hands‑on experience in ADC drug product formulation and process development, including a mechanistic understanding of linker‑payload attributes, stability and degradation pathways, and analytical strategies used to characterize ADCCQAs. 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 (e.g., aggregation, fragmentation, drug‑to‑antibody ratio, free payload, charge/size variants, subvisible particles, surface interactions) 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 and external stakeholders and participate in cross‑functional teams. Basic Qualifications Doctorate degree PhD OR PharmD OR MD [and relevant post‑doc where applicable] OR Masters degree and 3 years of Scientific experience OR Bachelors degree and 5 years of Scientific experience Preferred Qualifications PhD in Pharmaceutics, Biotechnology, Biochemistry, or related field with 24 years of postdoc 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. Strong foundation in analytical and biophysical techniques relevant to ADCs and biologics (e.g., UPLC/HPLC, SEC, IEX, RP‑HPLC, HIC, CE‑SDS, subvisible particle analysis, etc.). Familiarity with clinical‑stage development, manufacturability, and risk‑based decision‑making. Experience applying AI/ML (e.g., LLMs, in silico tools) to streamline R&D and optimize performance. Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs). What You Can Expect Of Us Amgen offers a comprehensive benefits package that includes a retirement and savings plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts. You will also benefit from a discretionary annual bonus program, stock‑based long‑term incentives, award‑winning time‑off plans, and flexible work models where possible. EEO Statement 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 commit to providing reasonable accommodation to individuals with disabilities to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. #J-18808-Ljbffr BioSpace