Senior Scientist, Quality Control Operations

Job Title

Senior Scientist, Quality Control Operations

Remote (WA or MA preferred). Candidates based in IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY or WA will be considered.

Senior Manager, Quality Control

$112,000 to $131,000

This is a newly created role at Aurion Biotech within the Quality Control Department. The primary responsibility of this position is to support completion of quality control deliverables to meet project timelines, ensuring delivery in accordance with regulatory and internal requirements. The individual will work closely with Quality Assurance leads and CMC Leads to achieve quality team goals.

• 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.
• Works with CMO on out‑of‑specifications and investigations as needed.
• Designs DS and DP stability studies, establishing expiry, and reviews protocols, data, and reports 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 updates and enabling data‑driven decisions.
• Works collaboratively and cross‑functionally to support activities that meet project milestones.
• Assists regulatory personnel with supporting documents related to regulatory filings.

• MS degree with 5+ years of experience, or a BS degree with 10+ years of 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 and 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.

• Detail oriented and effective time management.
• Ability to work cross‑functionally with excellent verbal communication and collaboration skills.
• Quality mindset with demonstrated ability to identify compliance gaps.
• Proficient use of MS Office products.
• Ability to use Smartsheet is preferred but not required.
• Ability to adapt to rapid changes and work in a fast‑paced team environment.
• Ability to work independently and with other team members.
• Ability to travel to CMO locations as needed.
• Strong interpersonal and communication skills; team player and willingness to work in an environment that requires individual initiative, accountability to the team, and professional maturity.

• Robust benefits: full health insurance for employees and their families, 401(k) matching, EAP, FSA, generous PTO.
• Total Rewards: competitive compensation ensuring all employees are rewarded.
• Perks and fun: paid parking, subsidized commuter passes, in‑office catered lunches, team events, community projects.