HOW MIGHT YOU DEFY IMAGINATION?You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.Process Development Senior Associate - Pivotal Attribute SciencesLiveWhat you will doLet’s do this. Let’s change the world. Amgen is a leading biotechnology company with a mission to serve patients around the world. As a science-based, patient-focused organization, we discover and develop innovative therapies to treat serious illnesses.Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces, and optimizes innovative analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers (“BiTEs”), live oncolytic viruses, and synthetic medicines.As a PD Sr Associate, the candidate 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.This position is located in our Thousand Oaks, CA office.Key responsibilities:
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
WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.Basic Qualifications:
Master’s degree OR
Bachelor’s degree and 2 years of working experience of Biochemistry, Analytical Chemistry, Protein Chemistry or related subject area OR
Associate’s degree and 4 years of working experience of Biochemistry, Analytical Chemistry, Protein Chemistry or related subject area OR
High school diploma / GED and 6 years of working experience of Biochemistry, Analytical Chemistry, Protein Chemistry or related subject area
Preferred 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
ThriveWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.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 offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.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.
