QC Analyst II / Senior QC Analyst - Quality Control

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

Exciting new opportunities as our QC team is growing! This position will support method qualification activities including authoring protocols/reports and execution of testing and will support IND activities. We are looking for expertise in ELISA, in-vitro potency and qPCR/ddPCR methods to support several method qualifications in QC in the next few months. Collaborate with cross functional teams including Process Development, Analytical Development, Technology Team, Manufacturing, Supply Chain and Quality Assurance.

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.

Responsibilities:

• Develop, perform, troubleshoot, and optimize AAV characterization assays including but not limited to qPCR, ddPCR, SDS-PAGE, Western Blot, ELISAs, AUC, CE-SDS, HPLC, and reporter gene-based cell assays using insect or mammalian cell lines
• Establish and qualify assay controls, standards, and references
• Maintain cell lines used for cell-based assays.
• Maintain complete and accurate records of all work performed
• Author and/or review IQ, OQ, PQ protocols and reports as well as standard operating procedures.
• Ensure maintenance and calibration of equipment including controlled temperature environments, analytical equipment, pipettes, etc.
• Ensure laboratory supplies and required inventory are maintained
• Participate in assay transfer activities to external CROs and/or GMP CMOs
• Manage contract testing lab relationships: set up assay capabilities, coordinate sample shipments, obtain results, and follow up on open action items
• Document, technically evaluate, interpret data, and trend results
• Review data for quality, consistency, and accuracy
• Write technical protocols and reports
• Perform method transfers, method qualifications, stability testing, etc. per approved protocol
• Conduct laboratory investigations as required
• Identify gaps, recommend process improvements, and implement changes
• Participate in continuous improvement projects and activities
• Mentor new hires

• Bachelor’s Degree in Biochemistry, Molecular Biology, or other relevant disciplines in life sciences AND 5 or more years of hands on experience in an assay development or QC laboratory environment OR
• Master’s Degree in Biochemistry, Molecular Biology, or other relevant disciplines in life sciences AND 3 or more years of hands on experience in an assay development or QC laboratory environment
• Strong knowledge of QC testing principles and procedures in cell culture (aseptic technique), cell-based assays, ddPCR, ELISA, SDS-PAGE, CE-SDS, AUC, Western Blot, etc.
• Experience with cGMP environments and audits
• Knowledge of equipment protocols and requirements
• Good laboratory documentation skills and protocol writing and revision experience
• Strong interpersonal and communication skills; written and oral
• Outstanding planning, organization, and multitasking skills
• Team player and meet project timelines
• Experience or knowledge of a wide range of analytical instrumentation with the ability to troubleshoot and monitor system suitability trends

Preferred Qualifications:

• Understanding of applicable regulatory requirements (21 CFR, USP, EP, ICH)

• 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
• LTD, Life and AD&D
• Professional development opportunities
• Team-building events
• Fully stocked kitchen

Encoded Therapeutics, Inc. 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.