Encoded Therapeutics Inc.
Analytical Sciences Specialist
Encoded Therapeutics Inc., Morrisville, North Carolina, United States, 27560
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
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
Qualifications
Education: Bachelor’s or master’s degree in molecular biology, Cell Biology, Biochemistry, Biotechnology, or a related discipline. Seeking 8 years of experience 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
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
Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.
If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.
#J-18808-Ljbffr
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
Qualifications
Education: Bachelor’s or master’s degree in molecular biology, Cell Biology, Biochemistry, Biotechnology, or a related discipline. Seeking 8 years of experience 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
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
Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.
If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.
#J-18808-Ljbffr