POSITION DESCRIPTION

Position            Specialist, Quality Control

Company          Vernal Biosciences

Location           Essex, Vermont

Website            www.vernal.bio

COMPANY BACKGROUND

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).

Job Summary

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.

Our team is comprised of creative, highly-skilled innovators who are engaged in research and technology development. This position is for a senior team member who will be involved with chemically upcycling wastes or undervalued feedstocks to produce new sustainable materials for the asphalt industry.
The focus of the Lead Scientist will include:
• Generating new ideas and collaborating with the research team to expand research capabilities
• Investigating new approaches for chemically upcycling wastes or undervalued feedstocks
• Propose creative low-cost chemistries, experimental design and implementation
• Chemical characterization of products through multiple methods, reaction mechanism investigations, and materials balance determination to help guide techno economic analysis and environmental impacts
• Review literature, write reports, assisting in writing proposals, and authoring peer-reviewed publications (when appropriate)
• Organizing and directing project activities and coordinating the efforts of a project team
• Supervising, interpreting and reviewing the applicability and accuracy of data and providing feedback to clients and project staff
• Planning, designing, coordinating, and controlling the progress of project work and communicating the progress to clients and senior management
The ideal candidate will have a PhD in Chemistry, or closely related field, with a strong background in synthetic organic chemistry or polymer chemistry. Experience in petroleum, coal, biomass, green chemistry, thermochemical/chemical conversion (liquefaction or extraction), asphalt or with producing asphalt products (or asphalt formation) is desirable.
Individuals will thrive in this position if they have a passion for innovation and problem solving, a desire to engage in a team-oriented culture, are detail-oriented, and possess strong verbal and written communication skills. Team members who excel in this position will have opportunities for future growth.
Starting Salary Range: $80,000 to $85,000 per year
We offer a comprehensive benefit package, including generous paid time off, flexible schedules, and tuition waivers for one free class at the University of Wyoming each semester. Our package includes a retirement plan (with an 8% employer contribution after one year and options to contribute to a supplemental plan), insurance (medical, dental, vision, and life) and an employee assistance program.
Submit resume and cover letter to Michelle Holmes, Human Resources Manager, by email at mholmes1@uwyo.edu. The position is open until filled.
WRI is an Equal Opportunity Employer.