Senior Analytical Method Leader for Oligonucleotide Programs

BioSpace; Thousand Oaks (CA); In loco; USD 170.000 - 210.000; Tempo pieno

Vantaggi offerti da questo lavoro

Retirement and Savings Plan

Medical, dental, and vision coverage

Flexible work models

Descrizione del lavoro

Amgen is seeking a senior Process Development Sr Principal Scientist in Thousand Oaks, CA. You will lead analytical method development and provide strategic leadership to advance late-phase programs through commercialization.

You will mentor a team of analysts, collaborate across PD, Manufacturing, Quality, and Regulatory, and help define analytical control strategies for product and process understanding. Excellent communication and writing are essential.

Competenze

• Experience in analytical method transfer and validation.
• Strong cross-functional collaboration.
• Experience with oligonucleotide or small molecule analytics.
• Excellent technical writing skills.

Mansioni

• Lead analytical method development for late-phase programs.
• Mentor analysts and lead ASTL team.
• Collaborate with PD, Manufacturing, QA, Regulatory.
• Prepare regulatory CMC sections and address inquiries.

Conoscenze

Excellent communication

Cross-functional teamwork

Analytical thinking

Technical writing

Formazione

PhD in Analytical Chemistry

PharmD

MD

MS degree

Bachelors degree

Strumenti

Mass spectrometry (MS)

UV spectroscopy

NMR

FTIR

Descrizione del lavoro

Amgen is seeking a senior Process Development Sr Principal Scientist in Thousand Oaks, CA. You will lead analytical method development and provide strategic leadership to advance late-phase programs through commercialization.

You will mentor a team of analysts, collaborate across PD, Manufacturing, Quality, and Regulatory, and help define analytical control strategies for product and process understanding. Excellent communication and writing are essential.