Director, Bioprocess​/Process Development - Pivotal Drug Substance

Position: Director, Bioprocess / Process Development - Pivotal Drug Substance
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. 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, 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 lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

** Director, Bioprocess / Process Development - Pivotal Drug Substance*
* ** What you will do*
* In this leadership role, you will be responsible for the development, characterization, scale‑up, and support of drug substance cell culture and purification processes to enable commercial advancement of programs from Phase II/III through marketing applications. Located in Cambridge, MA and/or Thousand Oaks, CA, you will lead and develop a multi‑site organization of 30+ scientists and engineers while driving program success, safety culture, technical excellence, innovation, automation, and digital strategies.

You will support a diverse portfolio of biologics, including monoclonal antibodies (mAbs), BiTEs, bispecifics, biosimilars, and other novel protein‑based modalities, and play a key role in advancing late‑stage and commercial drug substance strategies across Amgen's manufacturing network.

** Key Responsibilities*
* + Lead a high‑impact, multi‑functional drug substance organization integrating cell culture and purification disciplines across multiple sites.

+ Recruit, develop, and retain a strong and diverse team; manage portfolio prioritization and organizational resourcing.

+ Advance integrated drug substance processes through commercial process development, process characterization, lifecycle management, and control strategy development.

+ Partner with engineering, manufacturing, and external network collaborators to enable successful process transfer and commercialization.

+ Author and review global regulatory filings (IND/INDa/MA) and respond to regulatory agency questions.

+ Drive ideation, development, and deployment of innovative and differentiating bioprocess technologies.

+ Contribute to Amgen's scientific and regulatory eminence through publications, patents, and participation in external conferences and forums.

+ Serve as a member of the Drug Substance Technology extended leadership team and contribute to business, organizational, and change‑management strategies.

** 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.

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* Basic Qualifications:

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* + Doctorate degree and 4 years of scientific process development experience, OR

+ Master's degree and 8 years of scientific process development experience, OR

+ Bachelor's degree and 10 years of scientific process development experience And

In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

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* Preferred Qualifications:

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* + PhD in Biochemistry, Biochemical Engineering, Chemical Engineering, or related discipline

+ 10+ years of experience in biopharmaceutical process development

+ Minimum of 4 years of experience directly managing people

+ Deep expertise in either cell culture…