Process Development Senior Associate - Pivotal Attribute Sciences

Process Development Senior Associate - Pivotal Attribute Sciences What you will do

In this vital role you will participate in protein characterization studies to support regulatory filings using High Performance Liquid Chromatography (HPLC) / Ultra Performance Liquid Chromatography (UPLC) and mass spectrometry (MS). The candidate will also work to develop, qualify, and transfer analytical methods to Quality Control, and optimize and troubleshoot existing methods.

They will 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
• • Participate in the maintenance of Attribute Sciences instruments and assist the Attribute Sciences department in maintaining a phase appropriate good manufacturing practices (GMP) environment
• • With a focus toward evaluation of critical quality attributes, 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
• • Perform 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

We are all different, yet we all use our unique contributions to serve patients. Scientific professional we seek is an individual with these qualifications.

Master’s degree
OR
Bachelor’s degree and 2 years of Scientific experience
OR
Associate’s degree and 4 years of Scientific experience
OR
High school diploma / GED and 6 years of Scientific experience

• 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

We’ll support your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

• 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

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.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.