Process Development Senior Scientist, Late-Stag...
@ Amgen

Cambridge, Massachusetts, United States
On Site
Full Time
Posted 21 days ago

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XXXXXXXXX XXXXXXXXX XXXXXXXXX****** @amgen.com
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Job Details

Overview

Join Amgen’s mission of serving patients by working on late-stage drug product formulation and process development for biologics modalities such as monoclonal antibodies, BiTEs, and fusion proteins.

Key Responsibilities

  • Design, plan, and execute formulation and fill/finish process studies.
  • Develop technical project plans and comprehensive data packages.
  • Author and review protocols, reports, and regulatory documents.
  • Perform data analysis using statistical techniques and software.
  • Collaborate with management, cross-functional partners, and stakeholders.

Qualifications

Basic degrees with requisite scientific experience are required. Advanced degrees in Chemical Engineering, Biomedical Engineering, Biochemistry or related fields are preferred with post-doctoral or industry exposure in pharmaceuticals. Experience includes formulation development, process characterization, scale-up, and data visualization.

What You Can Expect

Amgen offers competitive benefits, a collaborative culture, opportunities for career development, and flexible work models including remote and hybrid arrangements.

Key skills/competency

  • Process Development
  • Formulation
  • Biologics
  • Process Characterization
  • Data Analysis
  • Regulatory Documents
  • Statistical Analysis
  • Project Management
  • Scale-up
  • Cross-functional Collaboration
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How to Get Hired at Amgen

🎯 Tips for Getting Hired

  • Research Amgen's culture: Understand their mission, values, and breakthroughs.
  • Customize your resume: Align skills with process development requirements.
  • Highlight technical expertise: Emphasize data analysis and formulation experience.
  • Prepare for interviews: Review regulatory and project management examples.

📝 Interview Preparation Advice

Technical Preparation

Review formulation and fill/finish processes.
Practice statistical data analysis exercises.
Familiarize with regulatory document standards.
Study scale-down model development examples.

Behavioral Questions

Describe a challenging project management situation.
Explain cross-functional collaboration experiences.
Discuss handling tight project deadlines.
Share experience adapting to process changes.

Frequently Asked Questions