Lead Biologics Drug Product & Process Development

Biopharma Careers; Thousand Oaks (CA); On-site; USD 142,000 - 192,000; Full time

Job summary

Amgen in Thousand Oaks, CA is seeking a Process Development Principal Scientist to join the Pre-Pivotal Drug Product Technologies group, leading formulation, process development, and regulatory support for diverse biologics.

You will design liquid and lyophilized formulations, evaluate CQAs, enable scalable fill/finish, and collaborate across functions to advance ADCs, oligonucleotides, and other modalities.

Qualifications

• Doctorate degree required.
• Experience in biologics drug product formulation development, stability assessment, process development, and/or fill/finish operations preferred.
• Experience with ADCs and/or oligonucleotides such as siRNAs is highly desirable.

Responsibilities

• Lead drug product design, formulation, process development, technology transfer, and regulatory documentation in support of diverse biologics pipeline.
• Collaborate across process development, research, analytical, regulatory, quality, and manufacturing teams to advance programs.
• Develop and characterize liquid and lyophilized formulations for biologics; build unit operation understandings for scalable development.
• Apply AI/ML and data science approaches to predictive modelling and decision-making.

Skills

Leadership

Cross-functional collaboration

Data analysis

AI/ML familiarity

Education

Doctorate in related field

MS in related field

BS with 4 years experience

PhD in Pharmaceutics/Biotechnology/Related Field

Tools

UPLC/HPLC

SEC

IEX

LC-MS

Stability testing

Job description

Amgen in Thousand Oaks, CA is seeking a Process Development Principal Scientist to join the Pre-Pivotal Drug Product Technologies group, leading formulation, process development, and regulatory support for diverse biologics.

You will design liquid and lyophilized formulations, evaluate CQAs, enable scalable fill/finish, and collaborate across functions to advance ADCs, oligonucleotides, and other modalities.