Reporting to the Head of GMP Operations, this individual is familiar with leading teams that are implementing GxP and non-GxP IT solutions that support clinical and commercial GxP manufacturing. In this role, you will work closely with all stakeholders (Quality, Manufacturing, MSAT and Engineering) to help identify, design, and maintain critical business applications at Vernal.
- Lead and manage the support of IT/OT infrastructure and applications.
- Act as the IT liaison between internal business partners and outside vendors.
- Collaborate with leadership to define Vernal’s IT/OT and Data Governance strategy
- Collaborate with Quality/Validation to ensure the IT/OT and Data Governance strategy aligned with Data Integrity requirements
- Lead project lifecycle activities such as planning, requirement gathering, design, build, validation, implementation, and post-implementation support of GxP applications.
- Ensure all GxP systems maintain compliance by managing product release and update cycles.
- Works with stakeholders to maintain GxP system and CSV SOPs.
- Responsible for all IT/OT change management and change control activities of the GxP platforms.
- Identify and promote new platform features and drive adoption.
- Provide technical expertise on integration technologies to simplify our system landscape and enhance user experience.
- Excellent problem solving, communication, and organization skills are required.
- Flexibility with changing priorities, ability to work well under pressure, and take on unfamiliar tasks is required.
- Ability to clearly communicate with end users is required.
- Ability to strategically plan, organize, and manage multiple projects simultaneously is required.
- Strong work ethic with an ability to meet deadlines is required.
- Some off-hours or evening work may be required.
- Bachelor or advanced degree in information technology/business solutions or equivalent work experience is required.
- Minimum of 10 years of pharmaceutical/biotech industry experience leading technology driven transformations.
- A minimum of three (3) years hands-on technical GxP enterprise system (QMS, ERP, LIMS, MES, etc.) experience required.
- Experience in development of Interfaces/Integration between GxP enterprise platform and other systems.
- Experience with the implementation and management of cloud/SaaS systems in GxP environments.
- Prior experience in pharmaceutical/biotechnology industry and an understanding of data integrity regulations (21 CFR Part 11).
- Experience in Project Management.
- Able to work effectively in a WFH environment using self-management principles.
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