Senior Biologics Process Development Scientist

Initial Therapeutics, Inc.; Thousand Oaks (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Amgen is seeking a Process Development Principal Scientist in Thousand Oaks to lead formulation, stability, and process development for complex biologics and ADCs. You will integrate analytical data, drive cross-functional collaboration, and contribute to regulatory submissions in a fast-paced environment.

The role emphasizes leadership, data-driven decision making, and applying AI/ML approaches to improve developability and scalability of drug products for clinical manufacturing.

Qualifications

• PhD in Pharmaceutics, Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field with 3+ years of industry experience.
• Proven experience in biologics drug product formulation development, stability assessment, and process development.
• Experience with ADCs and/or oligonucleotides (siRNAs) strongly preferred.

Responsibilities

• Lead formulation, stability, and process development for biologics and ADCs.
• Collaborate across analytic, regulatory, and manufacturing teams to advance candidates.
• Apply AI/ML and data science to predictive modeling and decision making.
• Mentor junior scientists and contribute to regulatory submissions.

Skills

Biologics formulation

Process development

Analytical characterization

Regulatory submissions

AI/ML in R&D

Education

Doctorate degree

Masters degree

Bachelors degree

Tools

UPLC/HPLC

LC-MS

IEX

SEC

Job description

Amgen is seeking a Process Development Principal Scientist in Thousand Oaks to lead formulation, stability, and process development for complex biologics and ADCs. You will integrate analytical data, drive cross-functional collaboration, and contribute to regulatory submissions in a fast-paced environment.

The role emphasizes leadership, data-driven decision making, and applying AI/ML approaches to improve developability and scalability of drug products for clinical manufacturing.