Process Development Associate

Career Category

Scientific

Job Description

Join Amgen’s Mission of Serving Patients

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.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Associate 

What you will do

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.

What we expect of you

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

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

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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.

Application deadline

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

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.

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Salary Range

74,503.35USD -100,798.65 USD