Principal Scientist Bioconjugation

Amgen•Thousand Oaks, CA

11d

About The Position

Join Amgen’s DSTS group within Process Development, which invents, develops, and implements drug substance manufacturing processes and technologies for synthetic and hybrid assets. The Principal Scientist will lead the development of efficient and sustainable manufacturing processes for bioconjugates, including antibody drug conjugates (ADCs), drive technology innovation, provide technical expertise, and develop and mentor staff. The role is located at Amgen’s Thousand Oaks, California campus.

Requirements

Doctorate degree (PhD, PharmD, or MD) and 2 years of scientific experience; or a master’s degree and 5 years of scientific experience; or a bachelor’s degree and 7 years of scientific experience.
Experience in bioconjugation process development and industrialization of bioconjugation manufacturing processes, with a record of scientific innovation and leadership in the pharmaceutical industry.

Nice To Haves

Doctoral degree and 4 or more years in the pharmaceutical industry, with expertise in bioconjugate process development, preferably antibody drug conjugates (ADCs) and HPAPI linker-payload synthesis.
Experience with GMP manufacturing and technology transfer to CMOs.
Demonstrated functional representation on a CMC or PDT team.
Ability to work in a dynamic, interdisciplinary environment to achieve results.
People-centered leadership skills, including building strong teams through mutual trust and respect, and demonstrating Amgen leadership attributes of inspire, accelerate, integrate, and adapt.
A proven record of publications, patents, and presentations.

Responsibilities

Lead a multidisciplinary project team in developing sustainable and cost-effective bioconjugate manufacturing processes at all stages of clinical development.
Drive bioconjugation technology innovation.
Support cGMP manufacturing and technology transfer to GMP production facilities.
Develop strategies to ensure process performance through process understanding, modeling, and characterization.
Guide project deliverables to successful completion and ensure timelines are met.
Work cross-functionally to deliver regulatory documents and support regulatory filings.
Serve as a technical expert and stay current in bioconjugation manufacturing.
Coach colleagues and provide career and scientific/technical advice.