Overview In this role, you will contribute to early-stage drug product development for complex biologics, with emphasis on ADCs and monoclonal antibodies. You will design and optimize liquid and lyophilized formulations, assess CQAs, and develop scalable fill/finish processes to support clinical manufacturing. You'll integrate formulation, analytical, and process data to guide design decisions, applying AI/ML to accelerate workflows. You will collaborate across functions to deliver robust, manufacturable products for clinical development and regulatory submissions. This is a hands-on, fast-paced opportunity to shape ADC product strategies within Amgen's mission to serve patients.
Compensation / Benefits- comprehensive employee benefits package
- retirement and savings plan with company contributions
- stock-based long-term incentives
- flexible time-off plans
- flexible work models where possible
- discretionary annual bonus or sales incentives
Responsibilities- Collaborate across process development, research, regulatory, and manufacturing teams to advance programs and communicate technical recommendations
- Plan and execute formulation and fill/finish studies for early-stage programs
- Develop and characterize liquid and lyophilized formulations for biologics, with emphasis on ADC drug product formulation and 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 and linker-payload integrity
- Apply machine learning, AI, and data science to predictive modeling and decision-making
- Ensure development approaches are phase-appropriate from discovery through clinical manufacturing
- Author technical documents, regulatory inputs, risk assessments, and tech transfer packages
- Support internal and external technology transfer activities and collaborate with CMOs/CDMOs
- Present findings to internal/external stakeholders and participate in cross-functional teams
Key requirements- PhD, PharmD, MD with relevant post-doc experience OR Master's with 3+ years of scientific experience OR Bachelor's with 5+ years of scientific experience
- Proven experience in formulation development, stability testing, and fill/finish operations for biologics; direct ADC drug product formulation experience preferred
- Strong understanding of linker-payload stability, drug-to-antibody ratio, and CQAs; experience in product/process comparability
- Analytical and biophysical skills (UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis)
- Experience applying AI/ML to R&D and decision-making; familiarity with in silico tools
- Experience contributing to regulatory submissions (CTAs, BLAs)
- Strong communication skills and ability to work in cross-functional teams
- cross-functional collaboration
- effective communication
- problem solving
- ADC drug product formulation
- biologics stability testing
- fill/finish processes for biologics
