Senior Scientist, Quality Control Operations

Aurion Biotech

Senior Scientist supporting quality control deliverables at Aurion Biotech. Collaborating to meet regulatory requirements and project timelines in a clinical-stage biotech environment.

Posted 5/12/2026full-timeRemote • Kentucky, Massachusetts, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Pennsylvania, South Carolina, South Dakota, Texas, Washington • 🇺🇸 United StatesSenior💰 $112,000 - $131,000 per yearWebsite

About the role

Key responsibilities & impact

Works with external QC laboratories to review and track GMP in process, release and stability testing
Real time review of DP release data during harvests and CoAs as part of a rapid release strategy.
Leads QC data compilation and shares in cross-functional settings.
Able to work with CMO on out-of-specifications and investigations as needed.
Designs DS and DP stability studies, leading to establishment of expiry. This includes protocol review, data review, and report review in collaboration with an external CMO.
Supports technology transfers through data and document review.
Participates in internal and external collaborations to ensure project deliverables are complete and on time by providing team updates and enabling data-driven decisions.
Works collaboratively and cross-functionally to support and implement activities to ensure the project milestones are met.
Be able to help support regulatory personnel with supportive documents related to regulatory filings.

Requirements

What you’ll need

MS degree 5+ years’ experience, or a BS degree and 10+ years’ experience in a relevant discipline (cell biology, biotechnology, or related field) in the pharmaceutical industry.
Experience with biological products is critical, experience within cell therapy is preferred but not required.
Working knowledge of cGMP requirements, pharmacopeial and relevant guidelines (EMA, FDA, ICH, USP, JP).
Experience working within a QC pharmaceutical laboratory.
Experience in lead roles is preferred but not required.

Benefits

Comp & perks

Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GMPdata compilationstability studiesprotocol reviewdata reviewreport reviewtechnology transfersregulatory filingsQC laboratory experiencebiological products

Soft Skills

collaborationcross-functional teamworkcommunicationdata-driven decision makingleadership

Certifications

MS degreeBS degree