Process Development Senior Associate - Pivotal Attribute Sciences

Responsibilities

• Participate in protein characterization studies using HPLC, UPLC, and mass spectrometry to support regulatory filings.
• Perform method development and qualification studies using HPLC, UPLC, and Capillary Electrophoresis platforms.
• Conduct chromatographic fractionation, peptide mapping, intact mass, and other LC-MS studies to support product characterization and comparability.
• Author results in laboratory notebooks and method development reports.
• Coordinate and perform attribute identification and characterization studies, including the isolation and analysis of chromatography fractions.
• Conduct accelerated stability studies to define therapeutic degradative pathways.
• Collaborate with partner organizations during commercial process development, characterization, and validation studies.
• Maintain Attribute Sciences instruments and assist in maintaining a phase-appropriate GMP environment.

Requirements

• Master's degree OR Bachelor's degree + 2 years of scientific experience OR Associate's degree + 4 years of scientific experience OR High school diploma/GED + 6 years of scientific experience.
• Experience with method development and product characterization for therapeutic proteins.
• Proficiency with HPLC, UPLC, and Capillary Electrophoresis platforms.
• Experience conducting LC-MS studies.
• Experience working within a GMP environment.

Preferred Qualifications

• Degree in Biochemistry, Analytical Chemistry, Protein Chemistry, or a related subject area.
• Excellent written and verbal communication skills.
• Ability to multitask and efficiently plan complex projects.
• Strong teamwork skills and a self-starter mindset.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Retirement and Savings Plan with company contributions.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.

About the Company

Amgen is a leading biotechnology company dedicated to discovering, developing, and manufacturing innovative human therapeutics. Since 1980, Amgen has focused on serving patients living with serious illnesses in therapeutic areas including Oncology, Inflammation, General Medicine, and Rare Disease.