Director, Biologics Analytics & Assay Innovation

BioSpace; Kansas; Hybrid; USD 120.000 - 150.000; Vollzeit

Benefits dieser Stelle

Remote work options

Healthcare benefits

Travel opportunities

Zusammenfassung

A healthcare organization is seeking a Director for Analytical Science and Technology who will oversee analytical methods and ensure compliance with regulatory standards. The candidate should have a Master's or PhD in a relevant field, a minimum of 6 years of experience in biologics, and strong communication skills. This position allows for remote or hybrid work options, making it ideal for experienced professionals looking to make an impact in the field.

Qualifikationen

• Minimum 6 years’ experience as a technical subject-matter expert for biologic IND and/or BLA submissions.
• Strong experience in analytical development and determining product-related impurities.
• Excellent verbal and written communication skills.

Aufgaben

• Oversee analytical method transfer and optimization.
• Collaborate with Regulatory Affairs for BLA applications.
• Review validation data for submissions.

Kenntnisse

Analytical development

Interpersonal communication

Project management

Problem-solving

Ausbildung

MS in chemistry or related field

PhD preferred

BS/BA required

Tools

HPLC

Mass spectrometry

NMR

Jobbeschreibung

A healthcare organization is seeking a Director for Analytical Science and Technology who will oversee analytical methods and ensure compliance with regulatory standards. The candidate should have a Master's or PhD in a relevant field, a minimum of 6 years of experience in biologics, and strong communication skills. This position allows for remote or hybrid work options, making it ideal for experienced professionals looking to make an impact in the field.