Process Development Scientist, Oral Drug Products

Amgen Inc. (IR); Thousand Oaks (CA); On-site; USD 112,000 - 151,000; Full time

Benefits offered by this job

Flexible work model

Stock-based incentives

Competitive benefits

Job summary

Amgen Inc. in Thousand Oaks, CA seeks a Process Development Scientist to support early clinical development of oral drug products. The role focuses on formulation and process development for IR tablets and amorphous solid dispersions (ASDs).

You'll work hands‑on in GMP settings, develop manufacturable methods, and collaborate with cross‑functional teams including Regulatory Affairs, Drug Substance Technologies, and external partners to enable clinical supply.

Qualifications

• Doctorate, Master’s with 2 years, or Bachelor’s with 4 years of scientific experience.
• Hands-on GMP manufacturing with ASDs via HME or SDD.
• Experience with IR tablets and roll‑out of regulatory docs (IND CMC).

Responsibilities

• Develop and optimize oral drug product formulations and processes for early clinical studies.
• Conduct lab studies to characterize materials, assess process performance, and establish manufacturability.
• Collaborate across DPT, Regulatory Affairs, and external partners.

Skills

GMP manufacturing

ASD formulation

HME & SDD processes

tablet compression

regulatory documentation

collaboration across functions

pharmaceutical material science

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Tools

GastroPlus

Simcyp

Job description

Amgen Inc. in Thousand Oaks, CA seeks a Process Development Scientist to support early clinical development of oral drug products. The role focuses on formulation and process development for IR tablets and amorphous solid dispersions (ASDs).

You'll work hands‑on in GMP settings, develop manufacturable methods, and collaborate with cross‑functional teams including Regulatory Affairs, Drug Substance Technologies, and external partners to enable clinical supply.