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.
- 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
- 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.
- Experience with cGMP environments and audits
- 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.