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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Director, Bioprocess Development: Pivotal Drug Substance

Live

What you will do

Let’s do this. Let’s change the world. In this role you will oversee the development, characterization, scale-up and support of drug substance cell culture and purification processes to enable commercial advancement of programs from Ph II/III to marketing applications.

Located in Cambridge, MA or Thousand Oaks, CA. You will lead teams of more than 30 staff in Cambridge and Thousand Oaks, to drive program success, continue a culture of safety, recruit strong and diverse talent, lead technology innovation, increase automation and enable digital strategies.

An ideal candidate would have deep technical savvy and understanding of cell culture bioreactor processes or downstream purification processes. The candidate should also have extensive experience in process development and characterization, implementation of new technologies, process control strategy, process validation, and authoring and reviewing process characterization reports and marketing applications. The candidate would also have a path toward growing toward an Executive Director position.

The programs represent a wide range of biologics molecules including mAbs, BiTEs, biosimilars, bispecifics, and other novel protein-based modalities.

Responsibilities

• Lead diverse, impactful multi-functional drug substance team that is comprised of an integrated cell culture and purification subject areas located in both Cambridge, MA and Thousand Oaks, CA.
• Develop and recruit strong and diverse staff and manage portfolio resourcing.
• Advance integrated holistic drug substance processes for Amgen’s multi-modal protein portfolio (mAbs, BiTEs, bispecifics, and biosimilars) for late stage clinical and commercial implementation. This includes commercial process development, process characterization, lifecycle management, development of control strategies as well as working with our engineering group to support transfer of process to internal and external manufacturing network partners.
• Author global filings including IND/INDa /MA and respond to Regulatory questions.
• Conceptualization, development, and deployment of differentiating technologies and establishing a culture of innovation.
• Contribute to Amgen’s external eminence at scientific and regulatory conferences and other industry forums.
• Serve as member of Drug Substance Technology extended leadership team and advancing the process development function. Work in partnership with management to develop plans that support the directions of the business, the implementation of major change efforts, and the refinement of organizational strategy.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Bioprocess Development professional we seek will possess these qualifications.

Basic Qualifications

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

Extensive expertise in cell culture bioreactor processing including control strategies, media design, scale down strategies or experience in downstream purification processes.

4 years of experience directly managing people

Preferred Qualifications

• PhD degree in Biochemistry, Biochemical or Chemical Engineering
• 10+ years of experience in biopharmaceutical process development
• Proficiency in providing scientific and engineering expertise to multi-functional teams to advance complex projects to completion and to interface on technical problem resolution.
• Ability to compile and statistically analyze data, draw appropriate conclusions and make presentations to cross-functional audiences and senior management.
• Detailed understanding of all stages of Late Stage process development for biologics: commercial process development, process characterization, process design, Process Performance Qualification (PPQ), regulatory filings and agency interactions.
• Experience in authoring marketing authorization applications
• Strong technical communication skills, both written and verbal, to interact effectively with all partners.
• Active participation in the scientific community through a record of peer-reviewed publications and/or patents, as well as active participation in industry forums and/or conferences.
• Established success developing staff, including effective feedback and coaching or mentoring

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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