Amgen
Process Development Associate Scientist - Pre-Pivotal Drug Product Technologies
US - California - Thousand Oaks
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About the role
- Join Amgen's Mission of Serving Patients
- At Amgen, if you feel like you're part of something bigger, it's because you are.
- Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases.
Responsibilities
- Develop and characterize liquid and lyophilized formulations for biologics, with particular emphasis on biologics drug product formulation, handling, and lab-scale sterile filling.
- Investigate biologics-relevant CQAs (e.g., aggregation, fragmentation, charge/size variants, subvisible particles, surface interactions) to inform formulation and process design decisions.
- Design, develop, and execute automated high-throughput formulation screening workflows to accelerate excipient selection, formulation optimization, and processability assessments.
- Develop and implement laboratory automation solutions, including robotic liquid handling systems and automated sample preparation workflows, to improve experimental throughput, reproducibility, and data quality.
- Utilize design of experiments (DoE), high-throughput experimentation, and automated data analysis pipelines to efficiently explore formulation design space and support data-driven decision making.
- Author/review guideline documents, technical protocols, technical transfer documentation, reports, product impact assessments, and regulatory sections in support of IND submissions
Requirements
- Bachelor's degree and 2 years of Scientific experience
- Associate's degree and 4 years of Scientific experience
- High school diploma / GED and 6 years of Scientific experience
Nice to have
- Understanding of physical/chemical stability of proteins and how process related stress impacts product quality.
- Preferred experience in biophysical analysis (Light scattering, DSF, AUC, FFF) and mass spectrometry (peptide mapping).
- Ability to learn and act on dynamic information at a rapid pace, hard-working and collaborative attitude
- Excellent oral and written communication skills for timely documentation, presentation, and discussion of scientific results for a fast pace and cross functional environment.
- Proven experience in formulation development and fill/finish operations for biologics
- direct biologics drug product formulation experience is strongly preferred.
- Hands-on experience with high-throughput formulation development, automated liquid handling systems (e.g., Hamilton, Tecan, Beckman Coulter, Opentrons, or equivalent), and robotic laboratory workflows.
- Experience implementing laboratory automation, workflow digitization, and electronic data capture to improve R&D productivity.
Compensation
- 90,442.55USD -122,363.45 USD
Benefits
- Apply machine learning, AI, laboratory automation, and data science to predictive modeling, workflow acceleration, and decision-making.
Company info
- Career Category Operations 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.
- If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team.
Equal opportunity
- 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.
- Please contact us to request accommodation.
- Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
- 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.
Visa & Work Authorization
- Sponsorship for this role is not guaranteed.
This listing is sourced directly from Amgen's careers page and normalized into a canonical job model.