Development Engineering

Join Amgen’s Mission of Serving Patients

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. Process Development Scientist

In this vital role you will join the Drug Product Technologies (DPT) in Thousand Oaks, California, is seeking a Process Development Scientist to support early clinical development of oral drug products for synthetic molecules. This hands-on laboratory position will focus on formulation and process development for platform immediate-release (IR) tablets and enabling formulations, including amorphous solid dispersions (ASDs). GMP manufacturing will focus primarily on enabling formulations, particularly ASDs, while also supporting platform IR tablets as needed.

Develop and optimize oral drug product formulations and processes for early clinical studies, including platform IR tablets and enabling formulations.

Conduct laboratory studies to characterize materials and formulations, assess process performance, and establish manufacturable approaches.

Collaborate with colleagues across DPT and partner functions, including Drug Substance Technologies, Attribute Sciences, Regulatory Affairs, Supply Chain, Pharmacokinetics and Drug Metabolism, Clinical Pharmacology, and Biostatistics, as well as external manufacturing partners and academic groups.

Master’s degree and 2 years of Scientific experience

Bachelor’s degree and 4 years of Scientific experience

Hands-on GMP manufacturing experience with amorphous solid dispersions (ASDs) produced by hot-melt extrusion (HME) and/or spray-dried dispersion (SDD), including development of manufacturing procedures.

Hands-on GMP experience with roller compaction and tablet compression for immediate-release (IR) tablets.

Academic or professional background in pharmaceutical sciences, materials science, bioengineering, or an engineering discipline.

In-depth understanding of pharmaceutical material science and how material properties affect formulation development, process performance, and manufacturability for early clinical programs.

Experience supporting FIH drug product development, including formulation and process development for immediate-release (IR) tablets.

Experience working with contract research or manufacturing organizations.

Experience preparing or contributing to regulatory documentation, such as IND CMC sections, and interacting with regulatory authorities.

Strong communication and collaboration skills, including the ability to work across functions and resolve project-related issues.

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. 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

Flexible work models where possible. 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.

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. 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. 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.