Overview In this role, you will lead drug product design and process development for Amgen's late-stage biologics, focusing on ADC formulation and tech transfer. You will integrate formulation, analytical, and process data to drive scalable, manufacturable products and apply AI/ML to accelerate decisions. You'll lead a matrixed team, coordinate with CMOs/CDMOs, and communicate program status to management. This is a high-impact role at the intersection of science, engineering, and regulatory strategy in a fast-paced environment.
Compensation / Benefits- comprehensive employee benefits package
- Retirement and Savings Plan with company contributions
- stock-based long-term incentives
- discretionary annual bonus
- award-winning time-off plans
- flexible work models where possible
Responsibilities- Lead planning, design, execution and documentation of lab studies for drug product design and process development; manage tech transfer
- Deliver progress reports and presentations to keep leadership informed on program status
- Author and review technical protocols, reports, and regulatory responses
- Develop and characterize liquid and lyophilized formulations for biologics with emphasis on ADCs
- Lead internal and external technology transfer activities with CMOs/CDMOs and liaise on troubleshooting during manufacturing campaigns
- Apply machine learning, AI, and data science to predictive modeling and decision-making
- Serve as Drug Product Team Lead to develop commercialization strategy and lifecycle management
- Manages a team of engineers and scientists to advance program objectives
- Collaborate effectively in a matrixed environment to drive efficiency and positive change
- Travel domestically and internationally up to 10% of the time
Key requirements- PhD in a related field OR PharmD/MD with scientific experience OR Master's with scientific experience OR Bachelor's with scientific experience
- 8+ years in pharmaceuticals/biotechnology (preferred)
- 5+ years in formulation and fill/finish process development, tech transfer, DOE/DOE-like design and regulatory writing (preferred)
- Experience with ADC drug product development considerations and regulatory strategy
- Strong analytical/biophysical technique background relevant to ADCs (UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, etc.)
- Programming experience (Python, R, MATLAB) and database languages (SQL); data visualization tools (Tableau, Spotfire, D3js)
- Experience with regulatory submissions, RTQs, and global multi-functional teams
- Knowledge of GMP/Device documentation and regulatory filings for biotech products
- Leadership in cross-functional teams and ability to drive programs in a matrixed setup
- Willingness to learn new technologies quickly
- leadership
- cross-functional collaboration
- problem solving
- ADC drug product formulation
- formulation and fill/finish process development
- statistical design and analysis of experiments
