Meet Life Sciences · 3 hours ago
Senior Analyst, Analytical Quality Control
Newark, CA
Contract
Onsite
Senior Level
6+ years expMeet Life Sciences is a company focused on the pharmaceutical and biotechnology sectors, and they are seeking a Senior Analyst, Analytical Quality Control to ensure the quality and integrity of drug substances and products. The role involves performing and reviewing analytical testing in a cGMP environment, with a strong emphasis on HPLC-based methods for biologics and collaboration across teams to support product release and continuous quality improvement.
ConsultingHuman ResourcesRecruitingStaffing Agency
Hiring Manager
Ty Ortiga
Responsibilities
Perform and review analytical testing of raw materials, intermediates, and finished drug products for release and stability, with a primary focus on HPLC (CEX, SEC, RP-HPLC)
Execute biological and physicochemical assays including ELISA, SDS-PAGE, and Western Blot as required
Accurately document, analyze, and report data in compliance with cGMP and data integrity (ALCO+) principles
Investigate out-of-specification (OOS), deviations, and laboratory events; contribute to root cause analysis and CAPA development
Author, review, and revise SOPs, protocols, assay worksheets, and quality records
Support laboratory equipment maintenance, qualification, and vendor interactions
Maintain laboratory readiness, inventory, and safety standards
Train and mentor junior analysts on laboratory techniques and procedures
Collaborate with Manufacturing, Quality Assurance, and Analytical Development teams to resolve quality issues and support process improvements
Qualification
Required
Bachelor's degree in Biochemistry or a related pharmaceutical/biotechnology discipline
6+ years of experience in a regulated pharmaceutical or biotechnology QC environment
Strong hands-on experience with HPLC methodologies (CEX, SEC, RP-HPLC); peptide or biologics experience preferred
Experience performing and peer-reviewing QC analytical data
Working knowledge of biological and physicochemical methods (e.g., pH, ELISA, SDS-PAGE, Western Blot)
Experience with cGMP compliance, documentation, and regulatory standards
Strong problem-solving, organizational, and communication skills
Preferred
Master's degree in a related scientific discipline
Experience authoring HPLC methods, SOPs, deviations, CAPAs, and change controls
Experience supporting analytical instrumentation calibration and vendor service activities
Company
Meet Life Sciences
Life Sciences Affects Us All.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Hannah Donaldson
Chief Executive Officer
Mustafa Husseyin
VP of Finance
Recent News
2024-05-29
2024-04-26
2024-01-31
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