Process Development Senior Associate - Pivotal Attribute Sciences

About the role

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Responsibilities

• Participate in protein characterization studies to support regulatory filings using High Performance Liquid Chromatography (HPLC) / Ultra Performance Liquid Chromatography (UPLC) and mass spectrometry (MS).
• Develop, qualify, and transfer analytical methods to Quality Control, and optimize and troubleshoot existing methods.
• Collaborate with other process development departments to support commercial process development and process characterization studies in support of marketing applications.
• Perform method development and qualification studies using HPLC, UPLC, and Capillary Electrophoresis platforms.
• Perform chromatographic fractionation, peptide mapping, intact mass, and other LC-MS studies to support product characterization and comparability studies.
• Author results in laboratory notebooks and method development reports, interfacing closely with Attribute Sciences Team Leads and Quality Control to transfer and troubleshoot qualified methods.
• Maintain Attribute Sciences instruments and assist the Attribute Sciences department in maintaining a phase-appropriate good manufacturing practices (GMP) environment.
• Coordinate and perform attribute identification and characterization studies, including isolation and analysis of chromatography fractions.
• Conduct and coordinate accelerated stability studies to define therapeutic degradative pathways.
• Perform evaluation of novel platform analytical technologies to help drive innovation.
• Conduct experiments to help answer questions from health authorities.
• Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications.

Requirements

• Masters degree
• OR Bachelors degree and 2 years of Scientific experience
• OR Associates degree and 4 years of Scientific experience
• OR High school diploma / GED and 6 years of Scientific experience

Qualifications

• Scientific background in method development and product characterization for therapeutic proteins
• Preferred Degree in Biochemistry, Analytical Chemistry, Protein Chemistry or related subject area
• Excellent written and verbal communication skills, ability to multitask, efficiently plan and follow through on complex projects
• A self-starter, and someone who values working in teams

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Schedule

Full time