Lead Scientist, Attribute Sciences – Process Development

BioSpace; Cambridge (MA); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, Dental, Vision coverage

Life and disability insurance

Flexible spending accounts

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models

Job summary

Amgen is seeking a Process Development Principal Scientist to lead analytical strategy within Attribute Sciences, partnering with Drug Substance, Drug Product, and QA to advance manufacturing processes. You will guide analytical development, method transfer, and regulatory submissions across internal and contract sites.

You will mentor teams, drive scientific innovation, stay current with analytic methodologies, and influence process improvements across the development spectrum.

Qualifications

• Doctorate degree (PhD/PharmD/MD) and 3 years of relevant experience
• Masters degree and 6 years of scientific experience
• Bachelors degree and 8 years of scientific experience

Responsibilities

• Lead attribute and analytical aspects of pivotal clinical process development programs
• Define analytical control strategies and methods for late-phase development
• Lead method transfer and support cGMP manufacturing at internal and contract sites
• Prepare technical reports and regulatory CMC sections; respond to health authority questions
• Drive product characterization for regulatory filings and reference standard qualification
• Evaluate Amgen platform and analytics to drive innovation in Process Development
• Mentor junior staff and provide scientific leadership

Skills

Leadership

Problem solving

Communication

Technical writing

Cross-functional collaboration

Mentorship

Education

PhD

PharmD

MD

MS

BS

Job description

Amgen is seeking a Process Development Principal Scientist to lead analytical strategy within Attribute Sciences, partnering with Drug Substance, Drug Product, and QA to advance manufacturing processes. You will guide analytical development, method transfer, and regulatory submissions across internal and contract sites.

You will mentor teams, drive scientific innovation, stay current with analytic methodologies, and influence process improvements across the development spectrum.