We are seeking a highly motivated and skilled candidate for the role of Scientist on our Analytical Development team. This candidate will be involved in method development, optimization and qualification to support the characterization of our oncolytic Herpes Simples Virus (oHSV) and lipid nanoparticle (LNPs) programs. This candidate will work as part of the analytical development team to establish phase appropriate methods for the oncolytic Herpes Simples Virus (oHSV) and/or lipid nanoparticle (LNPs) programs. The ideal candidate will be able to independently drive and manage projects within the analytical development group. This person should be excited by technical challenges and the ability to grow as a scientist as part of a novel viral gene therapy development team.
Day to Day Responsibilities and Opportunities:
- Lead method development and implementation to support oHSV and/or LNP product release, stability and characterization across Phase I-III requirements to support commercial readiness
- Experimental planning, study design and scheduling of development projects as well as routine testing across programs
- Support day to day execution of analytical analysis for process development activities to ensure robust process and product characterization
- Work collaboratively and lead internal and external support for assay technology transfer and qualification to CMOs and CTOs
- Provide guidance and expertise on methods development strategies and product characterization across the organization
- Provide leadership and mentorship to junior staff with the potential to manager 1-2 direct reports
- Support the development of new assays to improve detection and characterization of viral vectors and impurities across all viral programs
- Provide technical input to support regulatory filings.
- Author and manage protocols, laboratory data, and technical reports.
Required Education, Skills and Experience:
- B.S. degree in Biology, Biochemical Engineering, Biochemistry, Molecular Biology, or closely related field is required
- B.S. degree with 8+ years, M.S. degree with 6+ years, or Ph.D. with 1-3 years of relevant industry experience
- Experience with analytical development for product release, stability and characterization is required
- Proficiency in leading Phase II/III method development to support product potency and commercial readiness is highly desired
- Technical expertise in cell-based assays, ELISAs, qPCR and HPLC/ULPC is preferred
- Prior hands-on experience with viral and/or LNPs products is highly desired
- Managerial experience and a desire to mentor junior staff is desired
- Strong communication and organization skills, good working knowledge of MS office, JMP, GraphPad, SoftMax and other data plotting/graphing software
- Demonstrates attention to detail, meticulous record keeping and personal organization
- Ability to analyze, compile and present experimental data in oral presentations as well as in technical reports
- Strong technical writing skills to support method SOPs, protocols, and reports