Summary
The Senior Director of Facilities and Engineering will take a hands-on approach to lead and manage of all operational activities relating to the development and maintenance of all the facilities operated by Vernal Biosciences in a highly-regulated environment. The incumbent will lead engineering operations by managing capital improvements to the facilities such as construction projects, by sourcing, ensuring facility fit, installing, commissioning, and qualifying all assets, by managing associated budgets, and by hiring, leading, and developing the FE&M staff. Further, the Senior Director will keep the facility and equipment current with relevant local, national, and global standards and regulations. Success will depend on previous experience with complex project management, familiarity with industrial manufacturing equipment, and ability to lead cross-functional teams. Importantly, the incumbent will partner with Manufacturing Sciences, Technical Operations, Quality Assurance, and Regulatory to maximize transparency and cooperation across departments.
Responsibilities
- Manage all facilities, including construction projects, maintenance, and upgrades
- Drive all major facility decisions, including design, related to the base infrastructure and work spaces
- Lead commissioning of GMP manufacturing facilities and equipment
- Supervise information technology staff who design, implement, and maintain business and GMP networks
- Manage worksite and workplace environmental health, safety, security, and waste management
- Staff and supervise the FE&M department
- Oversee the tracking, implementation, and maintenance of equipment, including the oversight of metrology professionals
- Draft and manage budgets, budgetary changes, and timelines
- Contribute to workflows for the creation of QMS records (e.g., SOP, URS, IOQ, change control, CAPA)
- Cultivate a culture of shared success
Department Responsibilities
- Design, install, commission, calibrate, qualify, and maintain facilities and equipment
- Schedule all construction, maintenance, and repairs
- Ensure that all plans and work are documented in the QMS, electronic lab notebook, QbD system, document control system, ERP, or other CGMP system as appropriate.
- Coordinate with QC to fulfill metrology functions pertaining EMS, EHS, and facility/production systems
- Coordinate with EHS and/or Safety Consultants for site access and systems installation and maintenance
- Recognize, report, and assist in investigating deviations and unexpected events related to GMP equipment and facilities
- Oversee worksite contractors and vendors
Desired skills and background
- Degree in Engineering or Management
- 10+ years in CGMP environment with significant GDP experience
- In-depth knowledge of relevant FDA, EU, ICH guidelines and regulations
- Strong negotiating skills and attention to detail
- Project management skills, including scheduling and reporting
- Demonstrated proficiency with Quality System Records
- Communication skills including protocol writing, working directly with clients, vendors, consultants and contractors and recognizing and escalating issues impacting GMP
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
Summary
The Innovation Scientist is a motivated self-starter who is solution-focused, takes initiative, and can design and execute wet-lab experiments. The Innovation Scientist will be responsible for enhancing Vernal’s plasmid and RNA processes through innovative research and development. They will provide encouraging and supportive mentorship within the RNA Sciences group.
Responsibilities
- Initiate, execute, and finalize client work orders
- Develop and optimize RNA synthesis reactions
- Develop and apply analytical methods to RNA
- Design and review process initiatives and experiments
- Create and optimize plasmid and mRNA synthesis workflows
- Operate as a key player in cutting-edge research
- Report on project status and product critical quality attributes (CQAs)
- Compile & present on major findings and innovation initiatives
- Employ literature search, curation, and application towards innovation initiatives
- Provide valuable mentorship to inspire and assist innovative projects driven by Research Associates
- Enjoy the benefits of living in Vermont
Required skills and background
- Ph.D. in cell or molecular biology, biomedical or chemical engineering, biochemistry, or a related field
- 2-3 years in a post-doctoral experience
- mRNA: synthesis and purification, working knowledge of mRNA biology (e.g., sequence, structure)
- Molecular biology: Polymerase chain reaction (PCR), qPCR, RT-PCR, molecular cloning (e.g. Gibson or Golden Gate), agarose gel electrophoresis
- Deep understanding and practical knowledge of the scientific method and selection of experimental controls
- High attention to detail including organizing, planning, executing, and documenting experiments
- Communication skills including protocol writing, working directly with clients, PowerPoint
- Must be authorized to work in the United States
Desired skills and background
- Protein chemistry: polyacrylamide gel electrophoresis (PAGE), western blotting, other forms of immunoblotting (e.g. dot and slot blots), silver staining, AKTA or FPLC purification, Bioanalyzer
- Cell biology: cell line and primary cell culture maintenance, expansion, banking, transfection optimization
- Optimization through design of experiments (DOE, e.g. JMP)
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