The Associate Director/Director of Lipid Nanoparticle Technologies will lead LNP technologies, including formulation and fabrication services for GMP and RUO (Research Use Only) customers. The role will be responsible for developing versatile and scalable LNP manufacturing technologies, associated analytical methods, and novel LNP chemistries including targeted delivery. The incumbent will be responsible for LNP operations throughout the lifecycle of the product, including, but not limited to innovation, drug discovery, process development and improvement, investigations, and CAPAs. They operate as team leader and SME to design and direct studies and manufacturing processes, with specific responsibility for those unit operations relating to LNP formulation. Further, this position will support commercial engagement by representing Vernal’s excellence in all aspects of LNP formulations to our customers.
- Support the sales, GMP, and RUO production teams by performing preliminary evaluations of customer provided LNP formulations
- Prepare and adhere to project plans and timelines to support company objectives
- Establish and lead a LNP Technology group within the MSAT and RUO departments
- The LNP Technology group shall:
- Independently conceive, design, and conduct QbD/DOE studies for the characterization of LNP-related unit operations such as formulation, mixing, concentration, buffer exchange, analytics, storage, and packaging
- Develop methods to synthesize, isolate, and store LNP-mRNA
- Plan and execute Feasibility and Engineering batches to support Tech Transfer to GMP operations
- Be integrated with all aspects of LNP manufacturing at Vernal Biosciences (e.g., preparation of batch records, sampling plans, SOPs, protocols, and work instructions; oversight over raw materials, single-use technology, and facilities requirements; and coordination with customers, clinical sites, and manufacturing partners)
- Determine equipment design and validation requirements
- Define material attribute and process parameter setpoints and acceptable ranges
- Troubleshoot problems associated with manufacturing operations
- Document all work in electronic lab notebook or Quality Management System as appropriate
- Recognize, report, and investigate deviations
- Become an essential part of Vernal’s origin story
- Enjoy the benefits of living in Vermont
Desired skills and background
- Ph.D. in chemical engineering, cell or molecular biology, biochemistry, or a related field
- Understanding of LNP formulation CPPs, CMAs, CQAs
- Familiarity with automation and control of LNP mixing technology and TFF systems
- Previous experience with Clinical or Commercial pharmaceutical manufacturing
- Analytical methods: HPLC, UV/VIS spectrophotometry, DLS
- High attention to detail including planning, executing, and documenting experiments
- Communication skills including writing protocols, working directly with clients, generating technical reports, preparing submitted documents.
How to Apply
If you feel that you are a great match for this position and want to make a difference in the exciting field of next-generation therapeutics, then reach out to us at [email protected] and be sure to include your resume and cover letter. We look forward to hearing from you!
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