Director, Process Development: Pivotal Drug Substance

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, Process Development: Pivotal Drug Substance

Cambridge, MA

Live

What you will do

Let's do this. Let's change the world. In this vital 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 Ph II/III to marketing applications. An ideal candidate would have deep technical rigor and understanding of biotechnology purification processing. While located in Cambridge, 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. 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 programs represent a wide range of biologics molecules including mAbs, BiTEs, biosimilars, bispecifics, and other novel protein-based modalities.

Responsibilities

Lead diverse robust multi-functional drug substance team that is comprised of a coordinated cell culture and purification fields located in both Cambridge, MA and Thousand Oaks, CA .

Develop and recruit strong and diverse staff and handle portfolio resourcing.

Advance coordinated 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.

Ideation, 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

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 downstream purification processes including control strategies, scale down strategies, affinity chromatography, ion exchange chromatography, harvest technologies, ultrafiltration, viral filtration and continuous processing.

4 years of experience directly managing people

We are all different, yet we all use our unique contributions to serve patients. The top tier professional we seek is experienced with these 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-functional teams to advance sophisticated 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 optimally with all stakeholders

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

A culture of promoting and advancing internal talent.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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