Scientist - Analytical Science and Technology

Role Summary

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.

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 organization's 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.

Qualifications

• Required: BS in a relevant concentration with 6 years’ biopharmaceutical experience; MS with 4 years’ biopharmaceutical experience; Ph.D. with 1 year biopharmaceutical experience.
• Required: Must have experience with Bioassays especially PCR methods (such as ddPCR). Also preferable to have next generation sequencing and cell-based assay experience.
• Preferred: Ph.D. is preferred.
• Preferred: GMP and Automation experience is a plus.
• Required: Strong critical thinking and problem-solving skills.
• Required: Experience with method development, transfer, qualification, and validation.
• Preferred: Experience in gene/cell therapy field is a plus.

Skills

• Quality environment
• Business Partnering
• Operational Excellence
• Risk Management
• Stakeholder Management
• Collaboration
• Regulatory requirements knowledge
• Dealing with ambiguity
• Problem Solving Skills
• Leadership
• Communication skills
• Data Integrity
• Digital savviness