Senior Scientist, Quality Control Operations

📋 Description

• Collaborates with external QC laboratories to assess 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 swift release strategy.

• Leads the compilation of QC data and shares findings in cross-functional environments.

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

• Designs stability studies for DS and DP, facilitating the establishment of expiry dates. This involves protocol review, data analysis, and report assessment in partnership with an external CMO.

• Aids in technology transfers through the review of data and documents.

• Engages in both internal and external collaborations to ensure that project deliverables are timely and complete by providing team updates and supporting data-driven decisions.

• Works in a cooperative and cross-functional manner to support and execute activities that ensure project milestones are achieved.

• Assists regulatory personnel by providing necessary documents related to regulatory submissions.

⛳️ Requirements

• MS degree with 5+ years of experience, or a BS degree with 10+ years of experience in a relevant discipline (cell biology, biotechnology, or a related field) within the pharmaceutical industry.

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

• Familiarity with cGMP requirements, pharmacopeial standards, and relevant guidelines (EMA, FDA, ICH, USP, JP).

• Proven experience in a QC pharmaceutical laboratory setting.

• Experience in leadership roles is preferred but not essential.

🏝️ Benefits

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

• Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are recognized for their dedication and hard work.

• Perks and Fun: Paid parking, subsidized commuter passes, catered lunches in the office, team events, and community projects are just a few ways we connect, celebrate, enjoy, and uphold our values.