Principal Scientist Oligonucleotides

Amgen•Thousand Oaks, MA

13d

About The Position

Amgen is seeking a Principal Scientist to join the DSTS group within Process Development, which develops and implements drug-substance manufacturing processes and technologies for synthetic and hybrid assets. The role will lead development of efficient, sustainable oligonucleotide manufacturing processes, capacity-expansion projects, and technology transfers. The successful candidate will provide technical expertise, drive innovation, and develop and mentor staff. The position is based at either Amgen’s Thousand Oaks, California or Cambridge, Massachusetts 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.
Doctoral degree and 4 or more years of pharmaceutical-industry experience, with expertise in oligonucleotide process development.
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 and ability to build strong teams through mutual trust and respect.
Demonstrated Amgen leadership attributes of inspire, accelerate, integrate, and adapt.
Proven record of publications, patents, and presentations.

Responsibilities

Lead a multidisciplinary project team developing sustainable and cost-effective oligonucleotide manufacturing processes.
Work with cross-functional teams to develop strategies and implementation plans to expand production capacity and improve yield.
Drive oligonucleotide 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 completion of project deliverables 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 bioconjugate manufacturing.
Coach colleagues and provide career, scientific, and technical advice.