Senior Biologics Process Development Scientist

BioSpace; Thousand Oaks (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen is seeking a senior scientist to advance early-stage biologics formulation and drug product development. You will design liquid and lyophilized formulations, build scalable fill/finish processes, and author regulatory documentation.

The role requires hands-on HT formulation, DoE, and automation collaboration with data science and automation teams. You will contribute to innovative drug product development across modalities, supporting quality attributes, stability, and process

Qualifications

• Doctorate degree in a relevant field such as Pharmaceutics, Biotechnology, Biochemistry or related area.
• Experience in formulation development, stability testing and fill/finish operations for biologics.
• Strong background in DoE, high-throughput experimentation and data analysis.
• Experience applying AI/ML to streamline R&D and optimize performance.
• Skilled communicator contributing to regulatory submissions.

Responsibilities

• Design, develop, and optimize liquid and lyophilized formulations for biologics.
• Establish robust, scalable fill/finish processes for complex biologics.
• Author technical documents and support regulatory submissions.
• Develop automated formulation screening workflows to accelerate screening.
• Collaborate with automation, data science, and digital teams on integrated workflows.
• Perform DoE and HT experiments to explore formulation design space.
• Transfer tech and support CMOs/CDMOs as needed.
• Present findings to cross-functional teams and leadership.

Skills

High-throughput formulation

Robotic automation

DoE & data analysis

Regulatory document writing

Data-driven decision making

Collaboration across teams

Education

Doctorate degree (PhD/PharmD/MD)

Master's degree with 3+ years experience

Bachelor's degree with 5+ years experience

Tools

Hamilton automation

Tecan automation

Beckman Coulter systems

Opentrons

UPLC/HPLC

Job description

Amgen is seeking a senior scientist to advance early-stage biologics formulation and drug product development. You will design liquid and lyophilized formulations, build scalable fill/finish processes, and author regulatory documentation.

The role requires hands-on HT formulation, DoE, and automation collaboration with data science and automation teams. You will contribute to innovative drug product development across modalities, supporting quality attributes, stability, and process