Senior Principal Scientist, Biologics ADC Formulation

Initial Therapeutics, Inc.; Thousand Oaks (CA); On-site; USD 190,000 - 260,000; Full time

Job summary

Amgen is seeking a Process Development Senior Principal Scientist in Thousand Oaks, CA to lead drug product design, formulation, and process development for biologics, including ADCs. You will guide projects across formulation, analytical, and manufacturing interfaces while coordinating with CMOs/CDMOs.

You will apply cutting-edge technologies, oversee technical transfers, and drive regulatory readiness in a fast-paced environment, with travel up to 10% and strong leadership expectations.

Qualifications

• Doctorate degree PhD OR PharmD OR MD and 2 years of scientific experience; OR Masters and 5 years; OR Bachelors and 7 years.
• Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related subject area.
• 8+ years of experience in pharmaceuticals/biotechnology.
• 5+ years of experience including formulation and fill/finish process development, process characterization, tech transfers, and regulatory authoring.
• Proven experience in formulation development, stability testing, and fill/finish operations for biologics; direct ADC drug product formulation experience preferred.
• Experience integrating formulation, stability, and analytical data to advance ADC candidates is desirable.
• Strong foundation in analytical/biophysical techniques relevant to ADCs and biologics.

Responsibilities

• Lead planning, design, execution, and documentation of laboratory studies related to drug product design, formulation, and process development, and tech transfer
• Deliver progress reports and presentations to ensure management awareness and engagement of status and needs
• Author and review guideline documents, technical protocols, reports, regulatory submissions, and responses to regulatory questions
• Develop and characterize liquid and lyophilized formulations for biologics, with emphasis on ADC drug product formulation, handling, and lab-scale sterile filling
• Lead internal and external technology transfer activities, including collaboration with CMOs/CDMOs, process fit assessments, and troubleshooting during manufacturing campaigns
• Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision-making
• Serve as a Drug Product Team Lead to develop strategy in support of commercialization and life cycle management
• Manage team of engineers and scientists to advance program objectives
• Work effectively in a matrixed environment to influence change and relationships
• Willing to travel domestically and internationally up to 10%

Skills

Scientific experience

Leadership

Analytical thinking

Team collaboration

Education

PhD in relevant field

PharmD

MD

Masters in related field

Bachelors in related field

Tools

Python

R

MATLAB

SQL

Tableau

Spotfire

D3.js

SAS

JMP

UPLC/HPLC

Job description

Amgen is seeking a Process Development Senior Principal Scientist in Thousand Oaks, CA to lead drug product design, formulation, and process development for biologics, including ADCs. You will guide projects across formulation, analytical, and manufacturing interfaces while coordinating with CMOs/CDMOs.

You will apply cutting-edge technologies, oversee technical transfers, and drive regulatory readiness in a fast-paced environment, with travel up to 10% and strong leadership expectations.