Senior Process Development Scientist, Attribute Sciences

Amgen; Cambridge (MA); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Comprehensive employee benefits package

Discretionary annual bonus program

Flexible work models

Job summary

Amgen in Cambridge, MA seeks a Process Development Principal Scientist to lead analytical development for clinical processes. You will define quality characteristics, optimize methodologies, and drive innovation in a collaborative environment.

The ideal candidate has a doctorate with significant industry experience and a strong background in analytical techniques, ensuring compliance with regulatory standards. Join us to make a meaningful impact in patients' lives.

Qualifications

• PhD with 3+ years of industry experience or Master's with 6 years.
• Hands-on experience in analytical method validation.
• Knowledge of ICH and FDA guidance documents.

Responsibilities

• Lead analytical aspects of pivotal clinical process development.
• Define analytical control strategies for clinical programs.
• Drive product characterization support for regulatory filings.

Skills

Analytical leadership

Scientific problem-solving

Strong communication skills

Experience in analytical method development

Knowledge of GLP and GMP

Education

Doctorate degree (PhD or PharmD or MD)

Master's degree

Bachelor's degree

Tools

Chromatographic techniques

Spectroscopic techniques

Job description

Amgen in Cambridge, MA seeks a Process Development Principal Scientist to lead analytical development for clinical processes. You will define quality characteristics, optimize methodologies, and drive innovation in a collaborative environment.

The ideal candidate has a doctorate with significant industry experience and a strong background in analytical techniques, ensuring compliance with regulatory standards. Join us to make a meaningful impact in patients' lives.