Scientist/Scientist II, Nanotechnology Analytical Method Development
San Diego, CA
Poseida Therapeutics is seeking a highly capable and independent Scientist with hands-on experience in analytical method development to join our Nanotechnology group. This position will be part of the Analytical Chemistry team, where the candidate will focus primarily on laboratory work related to chromatography-based methods for the qualification/quantitation of lipids, proteins, nucleic acids, and drug/lipid metabolites, as well as methods for the biophysical characterization of nanoparticle drug products. These activities will directly support the discovery and development of novel, non-viral drugs for in vivo gene therapy and genome editing.
These may include, but are not limited to:
Lead bioanalytical method development campaigns utilizing tandem mass spectrometry (LC-MS/MS) in nucleic acid delivery using lipid nanoparticle (LNP) and other nanoformulations.
Work closely with Pharmacology teams to develop and execute methods assessing the pharmacokinetic (PK) behavior of novel nanoparticle nucleic acid formulations in rodent and higher-order species.
Support development and validation of methods for assessing the biophysical properties of nanoparticle drugs, with a particular focus on chromatography-based techniques, and work closely with Formulations and Chemistry teams to characterize novel nanoparticle formulations, including identification of critical quality attributes and assessing formulation stability.
Interface with various functional teams within the R&D organization to address the need for complex method development, including establishing necessary assay principles and identifying relevant equipment, managing deliverables, writing SOPs and transferring assays for execution.,
Oversee operation of various analytical instruments, HPLC/UPLC, LC-MS/MS, LC-ELSD, and maintain/troubleshoot as needed.
Represent Analytical Chemistry in multidisciplinary groups tasked with discovering and developing non-viral delivery systems for in vivo and cell-based gene therapy.
Provide technical presentations and detailed reports to internal and external stake holders.
Requirements, Knowledge, Skills and Abilities
PhD in Bioengineering, Pharmaceutical Science, Material Science, Chemistry, Biophysics, or related field with 2+ years of postdoctoral and/or industry experience (a combination of education and experience may be considered)
Deep understanding of the principles of analytical method development, and strong background in quantitative data analysis
Strong background in developing chromatographic assays using various detectors for the separation and qualification/quantification of lipids, proteins, polymers, or nucleic acids.
Strong hands-on experience in LC-MS/MS method development for the separation and structural identification of biomolecules, including lipids, from various matrices.
Demonstrated proficiency in developing extraction methods for chromatography-based assays to determine the presence and concentration of lipids and nucleic acids.
Exceptional history of innovation in the field of analytical method development, evidenced by compelling publication(s) and/or intellectual property record.
Exposure to the gene therapy filed, particularly drug delivery systems (LNP, AAV, Polymersomes), and/or lipid/polymer biophysics.
Familiarity with CMC concepts relevant for translation of complex, particle-based drug products, including LNPs, liposomes, polymersomes, and similar compositions.
Ability to multitask, independently organize time, and plan specifics of work.
Passionate about performing research leading to the treatment and/or cure of diseases.
Possess highly motivated and self-driven attitude with initiative.
Capable of working well with others; collaborating with cross-functional teams and external partners.
Who We Are and What We Do
Based in San Diego, Poseida Therapeutics is a clinical-stage biopharmaceutical company utilizing proprietary gene engineering platform technologies to create next generation cell and gene therapies with the capacity to cure. We are developing a broad portfolio of cell and gene product candidates in a variety of indications based on our core proprietary platforms, including our non-viral piggyBac® DNA Modification System, Cas-CLOVER™ site-specific gene editing system and nanoparticle- and AAV-based gene delivery technologies.
We are continually innovating and growing as we advance our clinical trial programs with what we believe to be transformational science. We are passionate about making an impact on the development of patient solutions with our CAR-T therapies in various cancers and gene therapies for rare diseases. Our wholly-owned portfolio of product candidates is specifically designed to overcome the limitations of current generation cell and gene therapeutics, including:
· P-BCMA-101, is an autologous CAR-T targeting BCMA that we are currently evaluating in an expanded Phase 1 clinical trial for the treatment of patients with relapsed/refractory multiple myeloma.
· Our lead “off-the-shelf” product candidate, P-BCMA-ALLO1 is an allogeneic CAR-T for patients with relapsed/refractory multiple myeloma. We expect to file an investigational new drug (IND) application and initiation of a Phase 1 clinical trial in the first half of 2021.
· We have initiated a Phase 1 clinical trial and are currently dosing patients for our second autologous product candidate targeting PSMA, P-PSMA-101, for the treatment of patients with metastatic-castrate resistant prostate cancer.
· P-MUC1C-ALLO1 for multiple solid tumors is currently in pre-clinical development with an anticipated IND filing expected in late 2021
· P-PSMA-ALLO1 is our allogeneic product candidate for metastatic castrate-resistant prostate cancer, currently in development with an anticipated IND filing and initiation of a Phase 1 clinical trial in late 2022.
· Designed to include two or more fully functional CAR molecules into a T cell, we also have preclinical studies ongoing with DUAL CAR (CD19/CD20) in B cell malignancies and DUAL CAR (BCMA/CD19) in multiple myeloma where we anticipate filing INDs and initiating Phase 1 clinical trials in late 2021 and 2022. We also expect to initiate a trial in an undisclosed target in solid tumors in the future.
Gene Therapy Programs
· We are currently developing P-OTC-101, a liver-directed gene utilizing our proprietary piggyBac® DNA Modification System in combination with AAV/nanoparticle technology. P-OTC-101 is development for the in vivo treatment of Ornithine Transcarbamylase deficiency, a rare disease of the liver
· P-MMUT-101 is our second gene therapy product candidate for rare liver disease, targeting Methylmalonic Acidemia.