Senior/Principal Scientist, Viral Vector Analytical Development
4 weeks ago
Our Opportunity…
The Senior/Principal Scientist, Viral Vector Analytical Development is a key role within our Technical Development, Manufacturing and Quality group who will be a scientific leader within Viral Vector Analytical Development. We're looking for an individual to contribute to building Obsidian's analytical sciences capabilities for process and product characterization, driving the development of the first autologous cell therapy product in our pipeline targeting solid tumors. You'll work collaboratively with the Analytical Development team as well as Manufacturing, Process Development, Regulatory, and Quality functions to develop analytical tools for the characterization of viral vectors and associated cell therapy products to support our clinical pipeline. As part of our Technical Development and Manufacturing department, you'll be a vital part of working to achieve Obsidian's vision by collaboratively translating innovative science into medical breakthroughs for patients.
This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.
You Will…
* Apply your expertise in developing, transferring, qualifying and validating analytical assays for viral vectors (retrovirus/lentivirus) to support the release and characterization viral vectors for cell therapies in all phases of clinical development.
* Design, plan, and execute experiments in Viral Vector Analytical Development, working both independently and as part of a multidisciplinary team of researchers, including partnering closely with the process development team.
* Collaborate effectively and establish strong relationships with external stakeholders including: partners and CDMOs/CTLs for establishment, qualification and validation of analytical methods to support manufacturing of viral vectors.
* Provide and apply technical expertise to the team to develop, qualify and facilitate technology transfer of assays to assess identity, purity, safety, and potency of viral vectors (e.g., retroviral vectors) and engineered cell therapies.
* Work closely with junior scientists to support their career growth and success in the lab, including mentoring on experiment design, data analysis with appropriate scientific rigor, and proper documentation in lab notebooks.
* Support introduction of new analytical technologies, analytical equipment, implementation of common reagents and controls, trending of data, and transfer of analytical methods.
* Author and review technical and scientific documents including study protocols and reports, validation documents, SOPs, and test methods.
* Act as subject matter expert in viral vector analytical development. Represent the Analytical Development function as needed for regulatory interaction and author relevant CMC sections in regulatory documents.
You Bring….
Core Qualifications
* Ph.D. in a relevant discipline (molecular biology, immunology, biochemistry, cell biology, virology or related field) with a minimum of 4+ years or MS and 7+ years or BS with 11+ years relevant industry experience including prior hands-on experience in retroviral and/ or lentiviral vector analytical development with a progressive track record of leadership and impact.
* Demonstrable experience with analytical development and method qualification/validation supporting early and/or late-stage development of viral vectors for cell and/ or gene therapy.
* Subject matter expertise in product characterization methods relevant to viral vector (including cell-based vector potency assays, infectious titer, titration assays, PCR / qPCR, ddPCR, sequencing, ELISA, MSD, and western blot).
* Strong troubleshooting, organization, and record keeping skills.
* Experience working with Viral Vector CDMOs/ CTLs for method transfer, development, qualification and validation.
* Working knowledge of cGMP and quality systems requirements.
* Ability to manage multiple responsibilities in parallel with minimal direction.
* A track record of leading teams to deliver critical goals while adapting to changing priorities.
* A leadership style orientated to high standards and support to succeed and grow. You engage input of team members, encourage open honest dialogue, and empower for ownership and accountability.
* A desire and ability to work in an entrepreneurial, collaborative environment building healthy, productive, and high trust relationships within your function and with direct stakeholders to effectively influence actions and decisions.
* Excellent oral and written communication skills.
Bonus Qualifications
* A track record with analytical development and method qualification/ validation for characterization of engineered cell therapies.
* Experience with cell line/ primary cell transduction/ transfection, cytotoxicity assays, Next Generation Sequencing.
* Experience with Design of Experiment (DOE) approaches and application to analytical development.
Job level (Senior or Principal Scientist) will be determined based on overall skillset and experience' according to Obsidian's job level criteria.
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