Senior Scientist, Quality Control Operations

This is a fully remote position, open to applicants in Kentucky, +11 more states.

📋 Description

• Collaborates with external QC laboratories to oversee and monitor GMP in-process, release, and stability testing.

• Conducts real-time evaluations of DP release data during harvests and CoAs as part of a rapid release approach.

• Takes the lead in compiling QC data and presenting it in cross-functional environments.

• Capable of working with CMOs on out-of-specifications and investigations as required.

• Develops DS and DP stability studies, contributing to the establishment of expiry dates. This involves protocol review, data assessment, and report evaluation in partnership with an external CMO.

• Aids in technology transfers through thorough data and document examination.

• Engages in both internal and external collaborations to ensure project deliverables are achieved on schedule by providing team updates and facilitating data-informed decisions.

• Works in a collaborative and cross-functional manner to support and implement initiatives aimed at meeting project milestones.

• Assists regulatory personnel with the necessary documentation related to regulatory submissions.

⛳️ Requirements

• MS degree with over 5 years of experience, or a BS degree with more than 10 years of experience in a relevant field (cell biology, biotechnology, or related area) within the pharmaceutical sector.

• Critical experience with biological products; experience in cell therapy is preferred but not mandatory.

• Proficient understanding of cGMP regulations, pharmacopeial standards, and applicable guidelines (EMA, FDA, ICH, USP, JP).

• Background working in a QC pharmaceutical laboratory.

• Experience in leadership roles is favorable but not essential.

🏝️ Benefits

• Robust Benefits: We provide comprehensive health insurance for employees and their dependents, along with all the essentials: 401(k) matching, EAP, FSA, and generous PTO.

• Total Rewards: We offer competitive compensation packages designed to recognize the hard work of all Aurion employees.

• Perks and Fun: Enjoy paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects—just a few of the ways we foster camaraderie, celebrate achievements, have fun, and uphold our values.