Senior Scientist, Analytical Science & Cell Therapy (Hybrid)

Aurion Biotech

Cambridge (MA)

Hybride

USD 140 000 - 155 000

Plein temps

14 jours+

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Avantages offerts par ce poste

Full health insurance
401(k) matching
Paid parking
Commuter subsidies
Catered lunches
Team events
Community projects

Résumé du poste

Aurion Biotech in Cambridge, MA, is seeking a Senior Scientist in Analytical Science & Technology to lead method transfers and validations at external CDMOs. You will author and review protocols, assess raw data, and generate technical reports, ensuring milestones are met in late-stage cell therapy development.

The role demands hands-on QC experience and a strong pharmaceutical regulatory mindset. You will interface with internal teams (Analytical Development, CMC, QA) and external labs to

Qualifications

  • 5+ years in Quality Control with Master’s degree (or PhD with 2 years QC).
  • 8+ years with Bachelor’s degree in QC.
  • Experience with method validations and USP verification.
  • Strong knowledge of cGMP, pharmacopeial guidelines.

Responsabilités

  • Lead method transfers and validations with external CDMOs.
  • Author protocols and review data and reports.
  • Troubleshoot analytical methods and support deviations.
  • Maintain assay validity monitoring tools and QC data.
  • Collaborate with CDMOs, AD, CMC, and QA.

Connaissances

Flow Cytometry
JMP
CDMO collaboration
Analytical method lifecycle

Formation

Master’s degree in relevant field
PhD in relevant field
Bachelor’s degree in relevant field

Outils

MS Office
Statistical analysis software (JMP)

Description du poste

Aurion Biotech in Cambridge, MA, is seeking a Senior Scientist in Analytical Science & Technology to lead method transfers and validations at external CDMOs. You will author and review protocols, assess raw data, and generate technical reports, ensuring milestones are met in late-stage cell therapy development.

The role demands hands-on QC experience and a strong pharmaceutical regulatory mindset. You will interface with internal teams (Analytical Development, CMC, QA) and external labs to

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