Senior Scientist, Translational and Nonclinical Bioanalytical Sciences
Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for pediatric CNS 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.
Encoded is seeking a Senior Scientist of Translational and Nonclincial Bioanalytical Sciences to perform and oversee the nonclinical biodistribution and dose-determining biochemical studies in the development of gene therapy products. The successful candidate will be a scientific leader that can expand our assays and methods to develop our understanding of in vivo vector biodistribution and transgene expression profile for gene therapy product and contribute to interpretation of nonclinical pharmacology and toxicology studies to support clinical development programs.
Ideal candidate will be enthusiastic, entrepreneurial scientist motivated to shape the development of gene therapy products. As an important member of the Translation research team, this individual will be responsible for method development, sample testing, data analysis and integration of results for proof-of-concept and pivotal non-clinical studies leading to regulatory filings. Strong analytical and method development skills with ability to perform and coordinate activities both within internal teams (research groups) and external partners (large animal CROs) are required.
- Contributes to the development and execution of bioanalytical studies for candidate gene therapy products, throughout the drug development lifecycle
- Provide high quality analytical assessments for tissue biodistribution and mRNA expression profiles with sensitive quantitative molecular biology tools like qPCR, digital droplet (dd)PCR, RT-ddPCR and other pertinent platform technologies.
- Familiar with sensitive and robust protein detection methods to detect and quantify tissue transgene protein expression profiles using biochemical methods like electrochemiluminescence (ECL)-based Immune assays on MSD platform, Luminex, mass spectrometry approaches and other technologies.
- Provide molecular biology expertise in the analysis and interpretation of results to integrate with the overall nonclinical studies
- Provide scientific monitoring and guidance on outsourcing studies for method transfer, troubleshooting, qualification and validation studies to support gene therapy development
- Author and review method development SOPs, qualification, validation and sample testing reports for regulatory submissions
- Succinctly and effectively communicate interpretations of nonclinical molecular biodistribution and biochemical studies at cross-functional meetings
- Stay updated with knowledge of regulatory agency nonclinical and gene therapy regulations/guidelines, and relevant scientific literature
- PhD in Biochemistry, Molecular Biology or equivalent
- 5+ years experience including industry including postdoctoral work in fast-paced environments
- Depth of experience in AAV gene therapy or related genetic therapies is essential.
- Broad knowledge and background in central nervous systems is a plus.
- Extensive knowledge in conducting molecular assays for DNA and RNA measurements with qPCR, digital droplet PCR, Reverse transcription-PCR methods in a variety of biological matrices. Familiarity with high-throughput nucleic acid purification platforms like KingFisher and sample quality systems like Bioanalyzer and TapeStation
- Deep analytical abilities to analyze, graph and complete statistical analysis of large-scale data sets using Excel, JMP, GraphPad Prism software programs.
- Strong bioanalytical skills and familiarity with approaches and methods to allow sensitive and robust quantitation of tissue expressed transgene protein including mass spectrometry methods
- Proficiency and practical knowledge of method development, troubleshooting, qualification and validation in accordance with regulatory guidelines
- Outstanding communication, presentation, and writing skills
- Personnel characteristics of integrity, teamwork, and commitment to excellence to fit with Encoded core values for success
- 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.