Senior Scientist – ADC Drug Product Process Development

BioSpace; Thousand Oaks (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Competitive compensation

Stock-based long-term incentives

Discretionary bonus

Flexible work model

Job summary

Amgen seeks a Process Development Senior Scientist in Drug Product Technologies to advance ADC and biologic drug product formulation. You will design robust liquid and lyophilized formulations, evaluate CQAs, and establish scalable fill/finish processes for clinical development in a fast-paced, collaborative environment.

The role emphasizes cross-functional teamwork, regulatory documentation, and applying cutting-edge technologies to deliver quality, manufacturable products.

Qualifications

• PhD/MD/PharmD with postdoc or industry experience as applicable.
• Advanced degree with substantial scientific experience in biologics
• Strong background in ADC drug product development and stability

Responsibilities

• Plan formulation and fill/finish studies for early programs.
• Develop liquid and lyophilized formulations for biologics incl. ADCs.
• Characterize CQAs and stability attributes for regulatory submissions.
• Coordinate with cross-functional teams for tech transfer and investigations.
• Apply AI/ML to predictive modeling and process optimization.
• Present findings to stakeholders and senior leadership.

Skills

ADC drug product formulation

Biologics formulation

Formulation development

Analytical data integration

Cross-functional collaboration

AI/ML applications in R&D

Education

PhD in Pharmaceutics/Biotechnology/Biochemistry or related field

Masters degree with 2 years of scientific experience

Bachelors degree with 4 years of scientific experience

Tools

UPLC/HPLC

SEC

IEX

RP-HPLC

HIC

CE-SDS

Job description

Amgen seeks a Process Development Senior Scientist in Drug Product Technologies to advance ADC and biologic drug product formulation. You will design robust liquid and lyophilized formulations, evaluate CQAs, and establish scalable fill/finish processes for clinical development in a fast-paced, collaborative environment.

The role emphasizes cross-functional teamwork, regulatory documentation, and applying cutting-edge technologies to deliver quality, manufacturable products.