Scientist - Analytical Science and Technology

Novartis • Durham, NC

5h • 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.
• Must have experience with Bioassays especially PCR methods (such as ddPCR).
• Strong critical thinking and problem-solving skills.
• Experience with method development, transfer, qualification, and validation.

Nice To Haves

• Also preferable to have next generation sequencing and cell-based assay experience.
• Ph.D. is preferred
• GMP and Automation experience is a plus.
• 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.

Benefits

• US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level