Director Process Development

Career Category

Job Description

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 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 Process Development

What you will do

Let’s do this! Let’s change the world! This leader develops a team within Pre-Pivotal Drug Substance who are responsible for the development and advancement of a large and diverse portfolio of Biologic therapeutic molecules from Research to IND and enables GMP supply for early clinical trials. The programs represent a wide range of biologics molecules including mAbs, multi-specifics, conjugates and other novel modalities. As the primary point of contact with key leadership partners in Research, Process Development and Clinical Manufacturing you will be responsible for the delivery of data packages to support therapeutic candidate selection as well as the development and tech transfer of drug substance processes for clinical manufacturing. You will ensure the successful drug substance process development deliverables including molecule and develop ability assessments, final clone selection, upstream and downstream process development, process characterization, viral clearance and tech transfer for clinical manufacturing. In addition, you will drive implementation of new technologies, including automation, digital innovation, predictive modeling, new manufacturing technologies and process intensification. You will also ensure regulatory filings and responses to questions are managed diligently and executed with quality and rigor.

Responsibilities

• Lead diverse high performing multi-disciplinary drug substance team of 20+ staff that is comprised of an integrated cell culture and purification disciplines located in Thousand Oaks, CA.

• Develop staff and manage resource allocation for portfolio advancement and technology development

• Advance integrated holistic drug substance processes for Amgen’s multi-modality portfolio for pre-clinical and clinical development. This includes molecule assessment, early process development and process characterization activities, as well as supporting transfer of processes to internal and external manufacturing networks.

• Author or review IND filings and respond to global Regulatory questions.

• Champion the ideation, development, and deployment of differentiating technologies and establishing culture of innovation.

• Contribute to Amgen’s external eminence at scientific and regulatory conferences and other industry forums.

• Serve as member of Drug Substance Technologies (DST) extended leadership team and contribute to advancing the process development function. Work in partnership with management to develop plans that support the direction of the business, plans for implementation of transformational efforts and contributes to organizational leadership.

What we expect of you

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

Basic Qualifications:

• Doctorate degree and 4 years of process development experience OR

• Master’s degree and 8 years of process development experience OR

• Bachelor’s degree and 10 years of process development experience

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

Preferred Qualifications:

• PhD degree in Biochemistry, Biochemical or Chemical Engineering

• 10+ years of experience in biopharmaceutical process development

• Demonstrated ability in providing scientific and engineering expertise to multi-funct