Process Development Senior Principal Scientist

BioSpace; Thousand Oaks (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Amgen in Thousand Oaks, CA is seeking a Process Development Senior Principal Scientist to lead drug product design and formulation development within the Pivotal Drug Product Technologies group. You will drive technology transfer, oversee cross-functional teams, and apply AI/ML to optimize formulation and process strategies.

The role emphasizes collaboration with CMOs/CDMOs, regulatory interactions, and delivering scalable, manufacturable biologics for late-stage programs.

Qualifications

• PhD/MD/PharmD with 2+ years of scientific experience or MSc with 5+ years of experience.
• Experience in ADC drug product formulation and process development.
• Ability to travel up to 10% of time.

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 inform management of status and needs.
• Author and review guidelines, protocols, reports, and regulatory responses.
• Develop and characterize liquid and lyophilized formulations for biologics, focusing on ADC drug product formulation and handling.
• Lead technology transfer activities, including CMOs/CDMOs collaborations and troubleshooting during campaigns.
• Apply machine learning, AI, and data science to predictive modeling and decision making.
• Serve as a Drug Product Team Lead to develop strategy for commercialization and lifecycle management.

Skills

Leadership

Drug product formulation

AI/ML data science

Cross-functional collaboration

Education

PhD/MD/PharmD with 2+ years

Masters with 5+ years

Bachelors with 7+ years

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Process Development Senior Principal Scientist

What you will do

Lets do this. Lets change the world. In this vital role you will join our Pivotal Drug Product Technologies group in Thousand Oaks, CA. This group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgens Late-Stage biologics.

The Senior Principal Scientist will provide technical and project leadership while integrating information generated by functionally diverse teams to ensure success through the commercialization process.

The ideal candidate will bring hands-on experience in ADC drug product formulation anddrug product process development, includinga mechanisticunderstanding of linker-payload attributes,stability/process-relevant degradation pathways, and analytical strategies used to characterize ADCCQAs. This candidate will integrate formulation, analytical, and process data to guide product design,applycutting-edgetechnologies (including AI/ML), and collaborate cross-functionally to deliver high-quality, stable, and manufacturable drug products for developmentin a fast-paced environment.

• 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 the status, progress, and future program and functional needs
• Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions
• Develop and characterize liquidandlyophilizedformulations for biologics, with particular 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 of a matrixed team to develop strategy in support of commercialization and life cycle management of Amgens pipeline
• Manage team of engineers and scientists to advance program and functional objectives
• Work effectively in a highly matrixed team environment to influence and inspire change, efficiency, and foster positive relationships
• Ability to travel domestically and internationally up to 10% of the time

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications

• Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experience
• OR
• Masters degree and 5 years of Scientific experience
• OR
• Bachelors degree and 7 years of Scientific experience

Preferred Qualifications

• Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related subject area
• 8+ years of experience in