Senior Scientist, ADC Drug Product & Formulation

Amgen SA; Thousand Oaks (CA); Híbrido; USD 140 000 - 190 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Total Rewards Plan

Flexible work models

Stock-based long-term incentives

Resumo da oferta

Amgen is seeking a Process Development Senior Scientist - Drug Product Technologies. You will join the Pre-Pivotal Drug Product Technologies group to advance ADC and biologics drug product formulation and process development in a fast-paced environment.

The role emphasizes designing scalable fill/finish processes, applying novel analytical strategies, and integrating formulation, analytical and process data to guide product design for clinical development.

Qualificações

• PhD in Pharmaceutics, Biotechnology, Biochemistry or related field with 2–4 years postdoc or industry experience.
• Proven experience in formulation development, stability testing and fill/finish operations for biologics.
• Demonstrated understanding of ADC drug product development considerations including linker-payload stability.

Responsabilidades

• Develop liquid and lyophilized formulations for biologics, with emphasis on ADC drug product formulation.
• Build process understanding across unit operations to support scalable drug product development.
• Apply AI/ML and data science to predictive modeling and decision making.
• Author technical documents, risk assessments, and regulatory sections.
• Collaborate cross-functionally with regulatory, manufacturing and analytical teams.

Conhecimentos

ADC formulation

Process development

AI/ML applications

Cross-functional communication

Formação académica

PhD/PharmD/MD+postdoc

Master's + 2 years experience

Bachelor's + 4 years experience

Ferramentas

UPLC/HPLC

SEC

IEX

RP-HPLC

HIC

CE-SDS

Descrição da oferta de emprego

Amgen is seeking a Process Development Senior Scientist - Drug Product Technologies. You will join the Pre-Pivotal Drug Product Technologies group to advance ADC and biologics drug product formulation and process development in a fast-paced environment.

The role emphasizes designing scalable fill/finish processes, applying novel analytical strategies, and integrating formulation, analytical and process data to guide product design for clinical development.