Process Development Senior Scientist

Job Description

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.

Job Responsibility

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/external stakeholders and participate in cross-functional teams

Requirements

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

Nice to have

PhD in Pharmaceutics, Biotechnology, Biochemistry, or related field with 2–4 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 is highly desirable
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 we offer

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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

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Process Development Senior Scientist - Drug Product Technologies

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