Process Development Senior Scientist - Pivotal Biologics Drug Substance Technology

Process Development Senior Scientist - Pivotal Biologics Drug Substance Technology

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – we reach millions of patients each year.

As a member of the Amgen team, you’ll 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 lie within them, you’ll thrive as part of the Amgen team.

Join us and transform the lives of patients while transforming your career.

In this vital role you will be responsible for development, characterization, scale‑up and support of drug substance processes to enable commercial advancement of programs from Ph II/III clinical trials to marketing application. Work in a coordinated group in which cell culture and purification scientists work together to advance Amgen’s rich, exciting and dynamic pipeline. With Amgen’s biology‑first approach, the position provides the outstanding opportunity of being able to work on multiple modalities from antibodies and oncolytic viruses to bispecifics and antibody‑drug conjugates.

• Apply established platform approaches and problem‑solving skills to rapidly tackle drug substance challenges and build robust processes with efficient experimentation.
• Drive innovation and apply out‑of‑the‑box thinking to contribute to technology development.
• Expand and develop skills in cell culture and purification, thereby further contributing to the integrated group.
• Participate in drug substance teams and collaborate cross‑functionally with analytical and drug product representatives to deliver drug substance manufacturing processes in a phase‑appropriate manner.
• Deliver process amenable to cGMP operation and carry out results of drug substance in a cGMP manufacturing environment.
• Author, or provide direction for the authorship of, technical report or CMC regulatory submissions which may require minimal additional editing.

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

• Doctorate degree (complete by 12/2025) OR
• Master’s degree and 3 years of life sciences experience OR
• Bachelor’s degree and 5 years of life sciences experience.

• Doctorate in Chemical Engineering, Biochemical Engineering, or other relevant sciences.
• Consistent track record of decision‑making and trouble‑shooting protein drug substance purification processes, preferably in a process development environment.
• Strong understanding and extensive hands‑on experience in protein chromatography, including affinity, ion exchange, and hydrophobic interaction chromatography.
• Experience in filtration operations, including ultrafiltration/diafiltration.
• Understanding of protein characteristics and critical attributes to direct product/process control strategies.
• Proven ability to independently identify, develop and implement scientific solutions to practical problems.
• Motivated self‑starter with excellent interpersonal and organizational skills.
• Leadership experience of progressively increased scope and ability to encourage and lead a group of scientists.
• Eminence in the scientific community through a sustained record of peer‑reviewed publications.
• Demonstrated success working with diverse team members in a dynamic, cross‑functional environment.
• Familiarity with design of experiments and statistical analysis of data.
• Knowledge of license applications and the drug development process.
• Exposure to cGMP manufacturing and CMC components of regulatory submissions.