Scientist - Analytical Science and Technology

Novartis•Durham, CA

7d•Onsite

About The Position

The Analytical Science and Technology (AST) Scientist leads activities for analytical method transfer, development and optimization, qualification, validation, troubleshooting and investigation. Location: This position will be located in Durham, NC and is a full time onsite role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Requirements

BS, in a relevant concentration with 6 years’ biopharmaceutical experience; MS with 4 years’ biopharmaceutical experience; Ph.D. with 1 year biopharmaceutical experience.
Strong critical thinking and problem-solving skills.
Experience with method development, transfer, qualification, and validation.

Nice To Haves

Experience in gene/cell therapy field is a plus.

Responsibilities

Leads method transfer, qualification/validation, trending across analytical network.
Performs lab experiments for troubleshooting, development and validation efforts.
Acts as analytical technical lead for one or more projects with guidance.
Works closely with Analytical Development group to transfer/co-qualify new methods.
Collaborate with internal and external testing labs to ensure successful completion of projects to the organizations' standards.
Assists with authoring experimental protocols/reports and regulatory submissions related to analytical.
Participates in assay troubleshooting and projects to improve method performance across network.
Supports OOS investigation and other non-conforming results and implement appropriate corrective and preventative actions.
Assists with responses to agency questions related to analytical methods/specification.
Other related QC and AS&T duties as assigned.