Senior Scientist, Process Development – Biologics

BioSpace

Thousand Oaks (CA)

On-site

USD 120,000 - 180,000

Full time

2 days ago
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Benefits offered by this job

Stock-based incentives
Time-off plans
Flexible work models

Job summary

Amgen is seeking a Process Development Senior Scientist in Thousand Oaks, CA. You will join the Pivotal Drug Product Technologies group to advance formulation development for biologics in a fast-paced, cross-functional environment.

The role emphasizes applying analytics, machine learning, and data science to drive formulation improvements, process understanding, and technology transfers for commercial and late-stage products.

Qualifications

  • PhD in pharmaceutics or related field with extensive postdoc or industry experience.
  • Experience integrating formulation, stability, and analytics for biologics.
  • Experience in formulation, fill-finish, tech transfers and SPC.
  • Familiar with AI tools and data visualization (Tableau/Spotfire).
  • Strong cross-functional collaboration and regulatory submission support.

Responsibilities

  • Conduct formulation and process development studies for pipeline products.
  • Plan, execute and document development studies with rigorous data analysis.
  • Apply statistical and data science methods to inform decisions.
  • Develop liquid formulations for biologics and co-formulations.
  • Support tech transfer to manufacturing sites and process changes.
  • Prepare regulatory sections and technical reports.

Skills

Biologics formulation
Process development
Statistical analysis
Data science / AI tools
Cross-functional collaboration
Regulatory submissions support

Education

PhD/Doctorate
PharmD
MD
Masters + 3 years of experience
Bachelors + 5 years of experience

Tools

Tableau
Spotfire
Programming

Job description

Amgen is seeking a Process Development Senior Scientist in Thousand Oaks, CA. You will join the Pivotal Drug Product Technologies group to advance formulation development for biologics in a fast-paced, cross-functional environment.

The role emphasizes applying analytics, machine learning, and data science to drive formulation improvements, process understanding, and technology transfers for commercial and late-stage products.

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