Amgen
Process Development Senior Scientist - Pre-Pivotal Drug Product Technologies
US - California - Thousand Oaks · Senior
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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.
- Build process understanding across unit operations to support scalable drug product development.
- 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.
- Partner with automation engineers, data scientists, and digital teams to deploy integrated automated workflows that support formulation development, stability studies, and process characterization.
- 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 technical documents, control-strategy inputs, risk assessments, IND/CTA regulatory sections, and tech transfer packages.
Requirements
- Doctorate degree PhD OR PharmD OR MD
- Master's degree and 3 years of Scientific experience
- Bachelor's degree and 5 years of Scientific experience
Nice to have
- Requirement 1 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 biologics drug product formulation experience is strongly preferred.
- Demonstrated understanding of biologics drug product development considerations, including protein degradation, quality attributes, and product/process comparability.
- Experience integrating formulation, stability, and analytical data to advance biologics candidates from discovery or preclinical development into clinical manufacturing is highly desirable.
- 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 designing and executing high-throughput formulation screening studies for biologics, including automated preparation, analytical characterization, and data analysis.
- Experience implementing laboratory automation, workflow digitization, and electronic data capture to improve R&D productivity.
Compensation
- 126,066.05USD -170,559.95 USD
Benefits
- Apply machine learning, AI, laboratory automation, and advanced 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.
- What we expect of you We are all different, yet we all use our unique contributions to serve patients.
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.