Associate III, Quality Control Chemistry
Core
Ensures laboratory and Quality systems compliance with cGMP standards and supports clinical/commercial product testing milestones.
Role type
Senior IC Quality Control Chemistry Associate
Builds
Release and stability testing data, validation reports, and method qualification documentation
Domain
Biotechnology / Pharmaceutical Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC operation, release/stability methodology knowledge, instrument troubleshooting, FDA/EMEA regulatory compliance, data integrity maintenance
Preferred skills
GMP experience, LC MS/Dissolution/Karl Fischer/GC techniques, small molecule/antisense oligonucleotide experience, project management
Technologies
HPLC, LC MS, Dissolution, Karl Fischer, GC
Responsibilities
Perform release and stability testing; author/review investigational protocols and validation reports; support method development and transfer projects; provide technical leadership in laboratory investigations; mentor peers; maintain laboratory systems for data integrity
Seniority
Mid-level, hands-on IC with mentoring responsibilities