Summary
The Microbial Fermentation Engineer is responsible for Microbial operations throughout the lifecycle of the product, including, but not limited to shake flask and high cell density fermentation, scale-up, process validation, investigations, process improvement, CAPA, and investigations. They conduct experiments to develop products and manufacturing processes, with specific responsibility for those unit operations relating to microbial fermentation. They will also perform research and analysis and propose studies to Customers and/or Top Management. Candidates experienced in molecular cloning, transformation, and cell banking are highly preferred.
Responsibilities
- Independently design and conduct QbD/DOE studies for the characterization of microbial operations such as cell banking, media development, fermentation, and storage.
- Plan and occasionally execute Scale-up and Engineering batches to support Tech Transfer to GMP operations
- 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, QbD, or Quality Management system as appropriate.
- Recognize, report, and investigate deviations
- Prepare batch records, sampling plans, SOPs, protocols, and work instructions
Desired skills and background
- Masters or PhD in chemical engineering, cell or molecular biology, biochemistry, or a related field
- Understanding of microbial fermentation CPPs, CMAs, CQAs
- Familiarity with molecular cloning and cell banking workflows
- Direct experience with Clinical or Commercial pharmaceutical manufacturing
- Analytical methods: HPLC, UV/VIS spectrophotometry
- 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
Diversity/Equal Opportunity
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 putting the job title in the subject line