Job Title: Scientist, Analytical Sciences/Quality Control
Job Number: 23948
Location: Cambridge, MA
We are seeking a highly motivated and skilled candidate for the role of Scientist on our Analytical Sciences 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. The primary role that this candidate will be tasked with will be to lead the characterization activities for the lipid nanoparticle (LNPs) program. 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 lipid nanoparticle (LNPs) characterization (i.e. HPLC/UPLC, DLS, capillary electrophoresis etc).
- Responsible for day to day execution of analytical analysis support 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 LNP methods and product characterization across the organization
- Provide leadership and mentorship to junior staff
- 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.
- Provide analytical support of on-going oHSV programs including plaque forming assays, viral titer assay, cell-based assays, ELISAs and qPCR
- 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 experience
- At least 2+ years of post-degree experience in industry setting is preferred
- Experience with analytical development and product characterization is required
- Prior experience in HPLC/UPLC development is strongly preferred
- Hands-on experience with viral and LNPs products is highly desired.
- Proficient in HPLC, cell-based assays, ELISAs and qPCR
- Strong communication and organization skills, good working knowledge of MS office, data plotting and 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
- A Strong technical writer to support method SOP, protocol and reports
- GMP experience a plus