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Mantra Bio is seeking an experienced scientist to lead analytical and assay development efforts within our process sciences group, directly supporting our exosome and extracellular vesicle (EV) therapy programs. A successful applicant will have prior hands-on experience with assay and analytical method development for biologics, and be comfortable in a fast, nimble culture.
Applicants should have current and extensive knowledge of biologics characterization assays, including HPLC and Flow Cytometry based methods. You will develop process characterization, in-process and release assays to support process development and manufacturing, then transfer selected assays to QC or CRO. You will be a key contributor in the development of our exosome therapeutic programs and will work cross-functionally with R&D, engineers, and data scientists to rapidly establish and qualify critical assays for the characterization of our exosome therapeutic products. You are operationally minded, able to run multiple projects in parallel, and willing to do what it takes to drive the team forward.
Responsibilities:
- Lead analytical method development for Mantra Bio’s exosome therapeutic development programs, currently in preclinical stage.
- Execute and improve currently established exosome characterization assays and protocols, including Nanoparticle Tracking Analysis (NTA), protein quantitation, vesicle and cell-based flow cytometry, and other plate-based assays.
- Develop, establish, and qualify new characterization assays for in-process and final exosome product samples.
- Play a central role in selection and interaction with contract manufacturers / research organizations, key suppliers, and other external vendors. Prior Experience with CMO/CRO highly desired.
- Tech transfer selected assays to in-house and CMO QC groups
- Manage the analytical development function at Mantra, including operational considerations, lab buildout and equipment purchases, team recruitment and training, setting key metrics and objectives.
- Evaluate and transfer in appropriate assays and improve their performance.
- Write protocols and development reports, and contribute to relevant regulatory filings.
- Exercise independent judgment in performing experimental methods, techniques, evaluation criteria for obtaining results, and data analysis.
- Present scientific results in team meetings and at conferences
- Maintain thought leadership with the current exosome therapy ecosystem and bring best practices to Mantra.
- Coordinate tasks across multiple projects, demonstrating prioritization and planning. We are a start-up and are looking for applicants who are ready and willing to ‘roll their sleeves up’ and be the Key Driver to meet project timelines and milestones.
What We’re Looking For:
- BS/MS degree with 6+ experience or PhD degree with 3+ years experience in a drug development setting.
- 4+ years of biologics analytical development experience using HPLC and flow cytometry systems is required.
- Familiarity with Design of Experiment (DOE) and comfort working with analytical tools to create high quality unbiased analyses.
- Prior experience with IND regulatory requirements (FDA), ICH, GMP environments, and quality documentation is highly desired.
- Demonstrated ability to work independently with minimal supervision.
- Prior method and protocol development for biologics, including, but not limited to chromatographic analysis using HPLC/UPLC for IEX, SEC, RP, HIC, HILIC, NP, and affinity chromatography, DSC, DLS, IEF/cIEF, SDS-PAGE, Western blotting, and flow cytometry, is required.
- Excellent interpersonal skills, including clear, succinct, and timely communication and proven ability to foster strong relationships with other team members and stakeholders.
- Highly self-motivated and detail-oriented, with proven ability to work in a dynamic, fast-moving team.
- Comfortable working with a data-driven team and collaborating with research scientists, data scientists and platform engineers.
