Analytical Sciences Specialist

Encoded Therapeutics·
Remote
2w ago
Full-timeSeniorAnalytical DevelopmentGenetic DisordersUnknownBachelors
$80K - $110K/yr

Description

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. This is a unique opportunity to work at the intersection of genomics and therapeutics and participate in the development of a diverse therapeutic pipeline driven by a transformative core technology. The successful candidate will work well across multiple projects in a fast-paced and dynamic environment. This position is part of the Analytical Sciences group at Encoded Therapeutics. **Requirements** • Perform routine analytical testing for cell-based potency assays, molecular assays (e.g., ddPCR, qPCR), and biochemical assays (e.g., CE, ELISA, Western blot, HPLC), as well as other analytical methods supporting GMP release and stability programs. • Assist in method optimization, qualification, validation, and transfer of analytical assays in accordance with ICH, USP, and internal GMP guidelines. • Serve as a technical resource for method troubleshooting, assay optimization, and data interpretation, acting as SME when needed. • Review and interpret analytical data, ensuring accuracy, completeness, and compliance with GMP documentation standards. • Draft and revise SOPs, test methods, protocols, and related GMP documents in alignment with Analytical Sciences and QA requirements. • Participate in OOS/OOT investigations, CAPAs, and change control processes. • Maintain accurate laboratory records and ensure equipment calibration, maintenance, and instrument readiness are completed on schedule. • Collaborate cross-functionally with Manufacturing and QA to support method transfer, technical assessments, and data quality. • Manage day-to-day laboratory activities, including coordinating testing schedules, prioritizing workflows, and ensuring efficient execution of Analytical Sciences operations. • Oversee general lab readiness by maintaining inventory, ensuring equipment calibration and maintenance are completed on schedule. • Support internal and external audits, regulatory inspections, and data requests. • Train and mentor other analysts as needed.

Requirements

• Bachelor's or master’s degree in molecular biology, Cell Biology, Biochemistry, Biotechnology, or a related discipline. Seeking 8 years of experiences with a Bachelor’s degree, or 6 years’ experience and a Master’s degree • Eight+ years of relevant experience in Analytical Sciences / QC environment in the biopharmaceutical or gene therapy industry. • Hands-on experience with cell-based potency assays, molecular methods (ddPCR, qPCR), and biochemical/protein assays (ELISA, Western blot, HPLC, capillary electrophoresis). • Familiarity with GMP documentation practices, data integrity principles, and regulatory expectations for biologics and gene therapy products. • Experience with method qualification/validation, including authoring related protocols and reports.
Encoded Therapeutics

Encoded Therapeutics

BIOTECHNOLOGY

Gene Therapy

LocationCA - South SF
Open Jobs4
Gene Therapy
View Company Profile

Pipeline

Transcranial Magnetic StimulationN/A
Longitudinal Study of Phenotypic and Developmental Severity in Patients With Dravet Syndrome With SCN/A
No InterventionN/A
GABA Blood LevelN/A
ETX101Phase 1/2