This is both a hands-on and strategic role where you will have the opportunity to lead Vernal’s cell-based potency assay/ immunoassay development. This role requires strong and independent problem-solving skills, agile, detail-oriented, strong technical background in cell culture, transfection, cell engineering, cell-based functional assay development, statistical analysis, experience with data reporting, documentation and cross collaboration.
Key Areas of Focus
- Design, develop, optimize, transfer, qualify and/or validate novel cell-based bioassays and immunoassays in accordance with GxP for assessing Vernal mRNA biological activity and function.
- Experience with mammalian cell transfection concepts and methods.
- Expertise in various functional assay technologies, such as cell line engineering to build reporter gene assays, ELISA, flow cytometry/multiplex assays, fluorescent microscopy, immune cell cytotoxicity assays, and/or effector function assays.
- Experience with various cell lines, primary immune cell isolation, culture, differentiation, and expansion.
- Draft and review SOPs, technical reports, and regulatory documents.
- Transfer analytical methods internally or to contract laboratories, manage internal experiments and trend internal method performance and specifications.
- Familiarity with design of experiments (DoE) related to functional cell-based assay development, optimization, and validation.
- Data review, analysis, graphing, reporting and presentation to internal and external audiences.
- Act as a technical resource in investigations, health authority inquiries and regulatory filings.
- Mentor and train junior scientists/associates/specialists as needed.
Essential Duties and Responsibilities
- Support Vernal’s policy, mission, and vision.
- Perform cell culture, transfection, cell engineering, and develop various potency and safety related cell-based assays.
- Develop, optimize and utilize platforms like ELISA, ELISPOT, flow cytometry, microscopy, fluorimetry and/or western blotting techniques for potency test readouts.
- Support the documentation related to potency assay development, qualification, and/or validation.
- Represent the analytical development team in internal discussions as required.
- Maintain and procure (when needed) required equipment per Vernal SOPs.
Professional Experience and Qualifications
- PhD degree in Cell & Molecular Biology, Biochemistry, Immunology or related disciplines with 1+ years of experience; MS degree with minimum 5+ years of experience; BS with minimum 8+ years of experience in biotech or pharma industry or academic lab with primary focus on mRNA product and/or biologics.
- Experience with primary culture of cell lines and primary cells, transfection, cell-based functional assays, ELISA, and multi-color flow cytometry.
- Experience in designing and qualifying analytical test methods for mRNA-based therapies.
- Direct experience in Analytical Development, Platform Development, or Quality Control is a plus.
- GMP/GLP experience in a biotech, pharmaceutical or clinical research organization is beneficial.
- Demonstrated ability to participate in cross-functional teams.
- Demonstrated ability to work independently, handle multiple tasks simultaneously, and escalate needs to meet critical timelines.
- Basic knowledge of GCP, GLP, ICH guidelines, FDA guidelines, and other applicable regulatory requirements.
- Excellent organizational, verbal, and written communication skills.
- Demonstrated ability to problem-solve and learn.
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