Process Development Scientist — Oral Drug Products (IR/ASD)

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

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