Process Development Associate – Pre-Pivotal Drug Product

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. 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 – Pre-Pivotal Drug Product

What you will do

Let’s do this! Let’s change the world!

In this dynamic role you will focus on early formulation development and physicochemical characterization to support for preclinical and clinical development programs. In doing so they will contribute to regulatory filings and to Amgen’s intellectual property. In addition, you will have the opportunity to apply innovative data science techniques to advance our high-throughput and digital workflows.

Responsibilities include:

• Assist in evaluating and implementing enabling drug delivery strategies for challenging molecules requiring specialized formulation approaches such as amorphous solid dispersion, lipid based formulations

• Support preclinical development of synthetic small molecules by conducting molecular assessment experiments such as solubility, stability and solid state characterization under the guidance of project lead.

• Analyze data, maintain timely documentation (i.e. electronic notebooks) and contribute to technical reports and presentations in a matrix team environment

• Coordinate with team members and external partners to meet defined tasks and project milestones

• Apply continuous improvement practices to enhance overall laboratory efficiency

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 a collaborative individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 4 years of Scientific experience OR

• Associate’s degree and 2 years of Scientific experience OR

• Bachelor’s degree

Preferred Qualifications:

• B.S. in Chemistry, Chemical Engineering, Materials Science, Pharmaceutical Science, or a related scientific field, plus at least one year of pharmaceutical/biotech industry experience.

• Proven understanding of solid-state characterization techniques (e.g., XRPD, TGA, DSC, particle size analysis, microscopy, surface area measurement, DVS)

• Strong time and resource management skills

• Excellent written and verbal communication abilities

• Previous Amgen internship or Co-Op experience

• Hands-on experience in research laboratories

• Proficiency with enabling tools such as lab-scale spray dryer; familiarity with UV fiber-optic dissolution/solubility systems and pKa/logP platforms

• Experience in early-stage formulation preparation and basic solid-state assessments (e.g. solution/suspension preparation; manual and automated salt screening, solid-state/polymorph screening)

• Familiarity with Good Documentation Practices (GDP) and electronic laboratory notebooks (ELNs)

• Experience applying statistical analysis and data visualization tools

• Problem solver with a proactive demeanor and ability to collaborate and work in a cross functional/multidisciplinary environment

• Abilities to take initiative, work independently, and be flexible in responsibilities

• Excellent written, verbal, and presentation skills – ability to distill, craft and present key messages relative to diverse audience requirements

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.

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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.