The Specialist, Quality Control will be responsible for supporting Quality Control functions including but not limited to incoming materials, in-process bulk drug substances, final drug product release testing, and 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.
• Develop, validate, and execute various analytical and compendial test methods, including but not limited to incoming materials, in-process bulk drug substances, and final drug product release testing, stability testing, and 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.
• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory and ordering of supplies, etc.
• Collaborate with Quality Assurance, Manufacturing, Analytical Development and Digital/ IT to provide support to the QC department.

Essential Duties and 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.
• 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 with analytical test methods such as HPLC, CGE, dPCR, ELISA, immunoblot etc. 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.

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 careers@vernal.bio and be sure to include your resume and cover letter. We look forward to hearing from you!

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: