Analytical Sciences Specialist

Encoded Therapeutics • Raleigh, NC

6d

About The Position

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. For more information, please visit www.Encoded.com. 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

• 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.

Responsibilities

• 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.

Benefits

• Comprehensive benefits package, including competitive employer premium contributions
• Meaningful stock option grants
• PTO, sick time and holiday pay
• Generous Parental Leave program
• Pre-tax medical and dependent care programs
• STD, LTD, Life and AD&D
• Professional development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees