Quality Control Manager
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 Analytical Development, Process Development, Regulatory Affairs, Translational, MSAT/MFG, and Quality Assurance groups at Encoded Therapeutics to develop, conduct, qualify, and/or validate nucleic acid, protein, chemistry, and/or cell-based assays for adeno associated viruses (AAV) along with safety related assays to support release testing of final product. The individual will provide technical leadership relative to the execution, development, optimization, troubleshooting, transfer, and qualification of molecular, biochemical, and chemical assays.
- Lead and manage day-to-day activities of QC operations
- Oversee qualification of assay controls, standards, and references
- Execute and manage stability and reference standard programs
- Participate in IND-enabling study designs (delivery device compatibility, container/closure, stability, accelerated/shipping stability)
- Develop, perform, troubleshoot, optimize, and provide quality and regulatory guidance for AAV characterization assays including but not limited to qPCR, ddPCR, SDS-PAGE, Western Blot, AUC, CE-SDS, ELISAs, HPLC, and reporter gene-based cell assays using insect or mammalian cell lines. Train and supervises others in those activities
- Author and/or review IQ, OQ, PQ protocols/reports and standard operating procedures
- Oversee evaluation, maintenance and calibration of QC equipment including controlled temperature environments, analytical equipment, pipettes, etc
- Supervise contract testing lab relationships: set up assay capabilities, coordinate sample shipments, obtain results, and follow up on investigations
- Manage assay transfer activities among external CROs, GMP CMOs, Contract Testing Labs, and Encoded QC
- Responsible for completion of method transfers, method qualifications, stability testing, etc. per approved protocols
- Document, technically evaluate, interpret data, and trend results. Review data for quality, consistency, and accuracy
- Support CMC regulatory submissions
- Represent QC function on CMC program/project teams
- Conduct laboratory investigations as required
- Maintain complete, contemporaneous, and accurate records of all work performed
- Identify gaps, recommend process improvements, and implement changes
- Participate in continuous improvement projects and activities
- Mentor and train new hires
- Bachelor’s or Master’s Degree in Biochemistry, Molecular biology or other relevant disciplines in life sciences.
- 8+ years’ hands on experience in a QC laboratory environment
- 2+ years prior supervisory or management experience required
- Strong knowledge of QC testing principles and procedures in AAV specific cell-based assays, qPCR, ELISAs, CE-SDS, SDS-PAGE, HPLC, AUC, Western Blot, Microbiological assays, compendial methods etc.
- Knowledge of equipment protocols and requirements
- Significant protocol writing and revision experience
- Experience with cGMP environments and audits
- Solid understanding of applicable regulatory requirements (21 CFR, USP, EP, ICH)
- Strong interpersonal and communications skills; written and oral
- Outstanding planning, organization and multitasking skills
- Must be a team player and exhibit a willingness to meet project timelines
- Demonstrated knowledge of a wide range of analytical instrumentation with the ability to troubleshoot and monitor system suitability trends
- 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.