Process Development Scientist

Amgen SA; Thousand Oaks, Northern (CA, KY); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Competitive benefits

Total Rewards Plan

Flexible work models

Job summary

Amgen in Thousand Oaks, CA is seeking a Process Development Scientist to support early clinical development of oral drug products for synthetic molecules. This hands-on role centers on formulation and process development for IR tablets and ASDs, with GMP manufacturing focus on enabling formulations.

Key responsibilities include developing and optimizing formulations, conducting studies to characterize materials and processes, and collaborating across DPT and regulatory, PK/PD, and external

Qualifications

• Doctorate, or Master’s with 2+ years of scientific experience, or Bachelor’s with 4+ years of scientific experience.
• Hands-on GMP manufacturing experience with ASDs, HME or SDD.
• Experience with roller compaction and tablet compression for IR tablets.
• Experience supporting FIH drug product development and regulatory documentation (IND CMC).
• Strong collaboration and communication across functions and external partners.

Responsibilities

• Develop and optimize oral drug product formulations and processes for early clinical studies.
• Characterize materials, assess process performance, and establish manufacturable approaches.
• Collaborate with DPT, regulatory affairs, PK/PD, and external partners.

Skills

ASDs

GMP manufacturing

IR tablets

HME

SDD

roller compaction

tablet compression

process development

regulatory interactions

cross-functional collaboration

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Tools

GastroPlus

Simcyp

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 Scientist

What you will do

Let’s do this. Let’s change the world. 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). Process characterization will support early clinical supply across these formulations. GMP manufacturing will focus primarily on enabling formulations, particularly ASDs, while also supporting platform IR tablets as needed.

Key Responsibilities

• 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.

What we expect of you

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

Basic Qualifications:

• Doctorate degree
• OR
• Master’s degree and 2 years of Scientific experience
• OR
• Bachelor’s degree and 4 years of Scientific experience

Preferred Qualifications:

• 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.
• Experience identifying and troubleshooting issues during GMP processing.
• 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.
• Experience with physiologically based biopharmaceutics modeling tools such as GastroPlus or Simcyp.

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.

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.

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.