The Specialist, Quality Control will be responsible for supporting Quality Control functions including but not limited to incoming materials, in-process bulk drug substances, and final drug product release testing, environmental monitoring of cleanroom facilities. He or she partners with manufacturing sciences and technology (MSAT), quality assurance, and operations to support applicable aspects of CDMO work. This individual will also have growth opportunities to learn different facets of the business including manufacturing and different aspects of CQV deliverables. This individual will also work with establishing the electronic laboratory information management system (LIMS).

Key Areas of Focus

• Uses Vernal’s quality systems and programs to promote high-quality standards and continuous quality improvement.
• Train and execute various QC tests, including but not limited to incoming materials, in-process bulk drug substances, and final drug product release testing, environmental monitoring of cleanroom facilities
• Support establishing and use of LIMS.
• Utilize the electronic quality management system (eQMS, Master Control) for writing, reviewing, and training on GMP documents and to document on-the-job training.
• Ensures compliance with FDA Good Clinical Practice (GCP) and Good Manufacturing Practices (GMP), EU, and ICH guidelines and regulations with respect to job functions at Vernal.
• Provides back-room support for health authority inspections and customer audits
• Ensures documentation is compliant with Vernal SOPs, formats, and regulatory requirements (protocols, amendments, etc.)
• Utilize Vernal’s eQMS and LIMS to ensure QC testing is properly executed.

Responsibilities

• Support quality policy, mission, and vision.
• Execute various QC tests, including but not limited to incoming materials, in-process bulk drug substances, and final drug product release testing, environmental monitoring of cleanroom facilities
• Support the development and documentation of QC tests under GMP guidelines and Good Documentation Practices.
• Represent the Quality Control organization in internal discussions.

Desired skills and background

• Bachelor’s degree in a scientific or engineering discipline or equivalent experience required.
• 0-5 years in a role familiar with the quality control organization.
• GLP/GMP 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.
• Experience or familiarity in quality control laboratory testing or environmental monitoring is a plus.
• 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.

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:

Please contact careers@vernal.bio with CVs or for more information