Encoded Therapeutics

Senior QC Analyst / QC Lead – 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. 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 Quality group at Encoded Therapeutics responsible for establishing and conducting cell-based, nucleic acid-based, protein-based, and chemistry-based assays for adeno associated viruses (AAV). The individual will execute, develop, optimize, troubleshoot, transfer, and qualify molecular, biochemical, and chemical assays.

Responsibilities:

  • Lead, 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
  • Accountable as technical lead to make decisions and troubleshoot QC methods
  • Responsible to evaluate methods being transferred to QC
  • Participate in IND-enabling study designs and executions (delivery apparatus compatibility)
  • Perform qualification of assay controls, standards, and references
  • Maintain complete, contemporaneous, and accurate records of all work performed
  • Author and/or review IQ, OQ, PQ protocols and reports
  • Participate in assay transfer activities to external CROs and/or GMP CMOs
  • QC Liaison for managing contract testing lab relationships: set up assay capabilities, coordinate sample shipments, obtain results, and follow up on open action items
  • Lead and perform method transfers, method qualifications, stability testing, etc. per approved protocols
  • Author and revise standard operating procedures
  • Write technical protocols and reports
  • Conduct laboratory investigations as required
  • Document, technically evaluate, interpret data, and trend results
  • Review data for quality, consistency, and accuracy
  • Represent QC in cross-functional meetings
  • Identify gaps, recommend process improvements, and support implementation
  • Participate in continuous improvement projects and activities
  • Mentor and train new hires
  • Manage one or two entry level analysts

Requirements

  • Bachelor’s or Master’s Degree in Biochemistry, Molecular Biology, or other relevant disciplines in life sciences
  • 5+ years’ 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.
  • Knowledge of equipment protocols and requirements
  • Good laboratory documentation skills and protocol writing and revision experience
  • Understanding of applicable regulatory requirements (21 CFR, USP, EP, ICH) is a desired.
  • Strong interpersonal, decision making and communication skills; written and oral
  • Outstanding planning, organization, and multitasking skills
  • Team player and exhibit a willingness to meet project timelines.
  • Should possess experience or knowledge of a wide range of analytical instrumentation with the ability to troubleshoot and monitor system suitability trends.

Preferred Qualifications:

  • Experience with cGMP environments and audits

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
  • Team-building events
  • Fully stocked kitchen
  • Purple Tie dry cleaning service
  • Fitness center

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.

#LI-CL1

Director/Associate Director – Clinical QA/GCP

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 will work closely with Clinical Operations, Translational, Supply Chain, MSAT, Regulatory, and Quality Assurance groups at Encoded Therapeutics to develop, implement, and manage clinical quality systems in accordance with GCPs/GLPs. This hands-on role will provide quality oversight to clinical operations, clinical trials, and any other clinical QA initiatives. The candidate will also be responsible for providing leadership to a growing clinical QA team inclusive of contractors/consultants.

Responsibilities:

  • Provide leadership, strategy, and compliance oversight in accordance with Good Clinical Practices (GCPs), Good Clinical Laboratory Practices (GCLP), and Good Laboratory Practices (GLPs) for internal processes and Clinical Service Providers (Clinical Investigator Sites, Bioanalytical Laboratories, Data Management Vendors, e-Diary services, etc.)
  • Develop, implement, and manage a risk-based quality governance and oversight program in compliance with GCP and GLP quality systems
  • Partners with QA and Clinical Operations to develop, author, review, and/or approve clinical quality assurance SOPs
  • Performs compliance review of clinical protocols, clinical study reports, investigator brochures, and any other clinical documentation
  • Serves as QA representative and single point of contact on clinical study development teams. Provides interpretation of applicable regulations and guidelines.
  • Conducts or supervises GLP and GCP training in accordance with global GCP standards
  • Plans, schedules, and conducts GCP, GCLP, and/or GLP audits as lead auditor or co-auditor.
    • Perform supplier risk assessments and evaluates for potential use; conduct and/or manage qualification audits of GCP suppliers and services
    • Create and implement clinical study audit plans. Performs routine and/or for-cause audits as required
  • Authors and issues audit reports, ensuring clear communication of audit findings and follows up on audit commitments
  • Drives audit preparation activities for GCP or GCLP Health Authority inspections. Ensure successful outcomes and/or follow up and drive coordination of audit responses
  • Manages and drives to completion all inspection commitments, post-inspection activities, and corrective and preventative actions in a timely manner

Requirements

  • Bachelor’ Degree in scientific or relevant disciplines in life sciences.
  • 8+ years of combined hands-on experience in GCP QA and Clinical Operations in a regulated therapeutic/pharmaceutical environment
  • 3+ years leading or managing a GCP function
  • Demonstrated mastery of GCP, GLP, GCLP regulations and standards. GVP experience is a plus
  • Solid understanding of applicable regulatory requirements (FDA CFR, EMA, ICH, ISO, GCP, any other global applicable laws and regulations). Working knowledge of ICH E6(R2) GCP guidelines
  • Experience with GCP and GLP environments and audits (performing and receiving)
  • Experience with Health Authority Inspections
  • Experience with QA Quality Systems
  • Significant procedure/protocol writing, revision, and reviewing experience
  • Experience with IND and BLA submissions
  • Strong interpersonal and communications skills; written and oral
  • Outstanding planning, organization and multitasking skills
  • Team player and exhibit a willingness to meet project timelines
  • Travel as required
  • Prior gene therapy experience is a plus

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
  • Team-building events
  • Fully stocked kitchen
  • Purple Tie dry cleaning service
  • Fitness center

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.

#LI-CL1

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

Requirements

  • 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)

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
  • 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.

#LI-CL1