This position is responsible for completing daily activities at Vernal Biosciences CGMP Operations manufacturing facility. In addition to being fully trained in production processes, the candidate executes manufacturing in strict compliance with Current Good Manufacturing Practices (CGMP), environmental health and safety (EHS) guidelines and any other regulations that may apply. Due to the production schedule, the work schedule for this position varies month to month but is generally during the first shift.
Key Ares of Focus
- Uses Vernal’s quality systems and programs to promote high-quality standards and continuous quality improvement.
- Ensures compliance with FDA Current Good Manufacturing Practices (CGMP), EU, and ICH guidelines and regulations and leads as SME to cross-functional groups within Vernal.
- Execute activities related to production planning for drug substance and drug product manufacturing.
- Ensures manufacturing documentation is compliant with Vernal SOPs, test methods and protocols.
- Train on Vernal’s SOPs to ensure appropriate codification of GLP/GMP procedures relating to manufacturing operations.
- Follows batch records, SOPs, and work instructions to ensure compliant operation.
- Manufacturing of commercial, clinical, and development drug products using the discontinuous manufacturing line.
- Set up, Disassembly, and Operation of discontinuous process equipment.
- In-process cleaning of equipment and process rooms.
- Dispensing, sifting, and bulk packaging of clinical and commercial products, manufactured in discontinuous line, and as needed, in continuous line.
- Maintain equipment and facility in an audit-ready state.
- Interface with relevant cross-functional groups necessary for the operation and maintenance of the facility and manufacturing and testing of drug substance and product.
- Ability to lift up to 50lbs, visual acuity, manual dexterity, and ability to distinguish between the colors red, yellow, blue, and green.
- Solid organizational, interpersonal, communication, and documentation skills.
- Ability to follow written and oral instructions in English.
- Basic computer skills and ability to learn new systems.
- Other duties, as assigned to support GMP Operations.
Desired Skills and Background
- Bachelor’s degree ideally focused in a scientific, technical or engineering discipline or the equivalent combination of education and experience (High School degree with a minimum of 2 years or an Associate’s degree with 0-2 years of experience in a regulated industry such as aviation, medical devices, or pharmaceuticals)
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 medicines 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. 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