Position Specialist, Quality Control
Company Vernal Biosciences
Location Essex, Vermont
Vernal Biosciences is an mRNA manufacturing and lipid nanoparticle formulation company that is transitioning its research-use-only business and technology to become a cGMP-compliant contract development and manufacturing organization (CDMO). Vernal’s products are known within the industry to be high purity and useful to all known use cases for mRNA, including vaccines, gene editing and regulation, immuno-oncology, gene replacement therapy, and more. Vernal’s planned growth, supported by Ampersand Capital and Dynamk Capital, includes a new 23,000 SF facility in Essex Vermont, to manufacture bulk clinical drug products. Vernal’s investors have an outstanding track record of building successful CDMOs, as the principal investors in and operators of Brammer Bio (now part of ThermoFisher Patheon), CMC Biologics (now AGC Biologics), Arranta Bio, and Vibalogics (both now part of Recipharm).
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.
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 under GMP guidelines and Good Documentation Practices.
- Represent the Quality Control organization in internal discussions.
Professional Experience and Qualifications
- 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.