The Analytical Development Senior Scientist will lead the development and validation of analytical methods to provide complex analyses of biomolecules, especially DNA and RNA. The successful candidate will be responsible for providing expertise relating to analytical method validation and QC systems in general as they pertain to cGMP production of biologic therapeutics. This position will also support internal manufacturing operations.
- Develop, optimize, qualify, and validate analytical methods for the quantitation and/or qualitative characterization of mRNA, plasmid DNA, proteins, lipid nanoparticles, and small molecules with limited supervision or guidance
- Perform bridging studies, conduct DOE for method robustness, prepare reference and suitability standards, generate ad hoc analytical methods to support PD
- Maintain analytical methods for receipt, in-process, and release testing in a state of validation that is fit for use
- Maintain stocks of critical reagents and supplies, including reference standard materials
- Develop and apply statistical methods as needed
- Document all work R&D in electronic lab notebook, QbD, or GMP system as appropriate.
- Provide reports for regulatory filings
- Perform or manage routine testing of raw materials, in-process intermediates, and finished products.
- Recognize, report, and investigate out-of-specification or unexpected results
- Mentor peers and junior level staff
Desired skills and background
- Masters or Ph.D. in cell or molecular biology, biomedical or chemical engineering, biochemistry, or a related field
- Familiarity with Regulatory and Compendial Requirements, including ICH and USP
- Expertise in nucleic acid or protein chemistry analyses such as HPLC, UV/VIS spectrophotometry, PCR, qPCR, RT-qPCR, gel electrophoresis, interpretation and analysis of DNA sequencing, LC/MS, polyacrylamide gel electrophoresis (PAGE), western blotting, other forms of immunoblotting (e.g. dot and slot blots), silver staining, Bioanalyzer, and/or DLS
- Method Optimization through design of experiments
- Deep understanding and practical knowledge of the scientific method and selection of experimental controls
- High attention to detail including planning, executing, and documenting experiments
- Communication skills including protocol writing, working directly with clients, Power Point
Vernal is an equal opportunity employer. We recognize the value of diverse, multifaceted approaches towards innovation and aim to incorporate diverse perspectives and experiences. We strive to build a safe, welcoming, and inclusive work culture.
At Vernal, you will offer knowledge-based solutions to help us address the growing demand for mRNA, lipid nanoparticle (LNP) mRNA, drug screening, and ultimately clinical supply of mRNA. Together, we will create the most integrated solution for mRNA vaccines and therapeutic R&D. Vernal will become the only one-stop-shop for our clients’ and partners’ mRNA needs, from concept all the way to clinical trials. The mRNA research associate or scientist will develop methods to synthesize, purify, and scale up mRNA. As a startup, we are seeking adaptable, creative thinkers who can independently foresee gaps and opportunities and who take the initiative to solve problems with a sense of urgency. We expect the work to be rewarding, fast-paced, and to offer ample opportunities to plan and create new solutions to help grow our business. Vernal will pay a competitive salary with generous benefits including health, dental, and vision insurance. Although hiring level will depend on experience, we expect to grow with our employees and are interested in a variety of backgrounds.
Vernal Biosciences is located in Colchester, Vermont, adjacent to Burlington which is home of the University of Vermont and the UVM Medical Center. Check out https://www.helloburlingtonvt.com/ for more information. The Burlington area, set on the shores of Lake Champlain, features the best of two worlds:
- Multicultural hub with great schools, restaurants, breweries, shopping, arts, and an affordable cost of living
- Gateway to the Green Mountains including world class hiking, camping, bicycling, and alpine and nordic skiing
Please contact [email protected] with CVs or for more information