Process Development Associate 

Let’s do this. Let’s change the world. In this vital role you join will the pivotal synthetic Attribute Sciences team, part of the integrated Pharmaceutical Attribute Sciences (iPAS) department, located in Thousand Oaks, CA. This team plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products.

The analytical scientist will work closely with a team of analysts and scientists responsible for the technical aspects of developing analytical tools to gain understanding of key quality attributes in product and process for late phase synthetic programs across small molecules, synthetic peptides, siRNA, and synthetic components of conjugates.  The Scientist will integrate and optimally utilize platform and in-depth product attribute knowledge to advance Amgen products and ensure success through pivotal clinical phases to marketing authorization application.

Key Responsibilities:

• Hand-on experience in sample preparation and analysis of synthetic in-process samples, lot release samples, and drug product formulations using primarily chromatographic and spectroscopic techniques.
• Under the guidance of a supervisor, apply established methodologies and techniques to execute and validate analytical methods for testing drug substances and drug products across synthetic modalities, including small molecules, synthetic peptides, siRNA, and the synthetic components of antibody–drug conjugates (ADCs).
• Organize and document analytical data under Good Documentation Practice using electronic laboratory notebook system.
• Provide and present results in consultation with supervisor to support drug substance and drug product development.
• Transfer analytical methods to contract manufacturing or contract testing labs.

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

Basic Qualifications:

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

Preferred Qualifications:

• Bachelor’s degree in Analytical Chemistry, Organic Chemistry, Physical, Pharmaceutical, Life Sciences, Engineering, or relevant.
• Strong analytical experience with small molecules, synthetic peptides, siRNA, and/or antibody–drug conjugates, combining scientific knowledge, research capability, and hands-on laboratory expertise to support process development, scale-up, and formulation development activities.
• Experience with operation, maintenance, and troubleshooting of laboratory equipment and instrumentation, especially chromatographic (e.g. liquid chromatography and gas chromatography) and spectroscopic instruments (e.g. mass spectrometry).
• Experience in laboratory settings within the pharmaceutical or biotech industry
• Technical aptitude for identification, development, and implementation of novel analytical technologies, such as mass spectrometry (MS), vibrational spectroscopy, or nuclear magnetic resonance (NMR) etc.
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Sponsorship for this role is not guaranteed.

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Salary Range