Career CategoryProcess Development
Job Description
Process Development Associate
Duties: Perform method development and qualification studies using High Performance Liquid Chromatography (HPLC), Ultra-High Performance Liquid Chromatography (UHPLC), and Capillary Electrophoresis (CE) platforms; Perform chromatographic fractionation, peptide mapping, intact mass, and other Liquid Chromatography – Mass Spectrometry (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; 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; and Perform experiments to help answer questions from health authorities; and Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications.
Requirements: Bachelor’s degree (or foreign equivalent) in Chemistry, Chemical Biology or related field & 2 years of experience in the job offered or a research-related occupation. Position requires 2 years of experience in the following:
- Analytical chemistry experience for protein molecules, and completion of project deliverables including: designing and conducting degradation experiments, extracting and analyzing results via dedicated software: Empower, Chromeleon, and ChemStation;
- Liquid Chromatography principles, including the concepts of stationary and mobile phases, partitioning and separation based on different affinities;
- Analytical method development (chromatography and mass spectrometry), technologies and instrumentation including: High Performance Liquid Chromatography (HPLC), Liquid Chromatography – Mass Spectrometry (LC-MS), Solo Variable Pathlength Extension (SoloVPE), and Capillary Electrophoresis (CE);
- Method qualification and transfer for analytical instruments, along with data analysis and statistical evaluation of experimental results;
- Application analytical instrument troubleshooting across different platforms: Waters, Agilent, and Maurice;
- Analytical deliverables for pharmaceutical processes and product development;
- Data analysis, statistical analysis and method qualifications and transfers;
- Technical knowledge of proteins and peptides;
- Implementing Standard Operating Procedures in a laboratory environment in accordance with good laboratory practices (GLP) standards; and
- Recording experimental conditions, results and observations in a laboratory notebook.
Contact: Interested candidates please apply via and search for job # R-255469.
Job type: Full-Time position. The annual salary range for this position in the U.S. is $91,125.00 - $108,296.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for 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.
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.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
- 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, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.