Director/Senior Director, Manufacturing and Process Development
Vyriad is a clinical-stage, privately held biotechnology company based in Rochester (MN), focused on the development of powerful first-in class oncolytic virotherapies. Our Oncolytic virotherapy platforms utilize bioengineered virotherapies designed to selectively and rapidly destroy cancer, with the aim to potentially create “a single shot to cure cancer”. We have exclusively licensed the Vesicular Stomatitis Virus (VSV) and Measles Virus (MV) Oncolytic platforms, originally developed in the laboratories of our founders Drs Stephen Russell and Kah Whye Peng at Mayo Clinic and Dr Glen Barber at University of Miami.
Vyriad maintains a vibrant and transformative oncolytic virotherapy pipeline by continuously creating and testing cancer-fighting viruses engineered in different ways, and combined with various drugs, to destroy cancer cells directly as well as harness and enhance the body’s natural tumor-killing immune responses
Vyriad is building a state of the art GMP manufacturing facility in Rochester (MN).
We are looking for a Dir/Sr. Director who will support the facility construction and upon completion will be responsible for strategic direction and daily on-site operations, including manufacturing and process development for Vyriad’s oncolytic virotherapy platforms.
The initial focus will be to finalize the construction of the facility and facilitate the tech transfer of the cGMP manufacturing process of our lead product Voyager-V1. Other key responsibilities include hiring and managing the manufacturing team, supporting our R&D efforts by spearheading the cGMP engineering and manufacturing of the future innovative OVs to bolster the company product pipeline.
You will play a significant role in the transition of the company from construction and successful tech transfer to routine operation goals. Engaging external consultants as well as key internal functions including Quality Assurance, Quality Control, Facilities, Supply Chain, Manufacturing Sciences & Technology, Process Development, Human Resources, and Finance will be paramount toward establishing a vision and execution of the manufacturing strategy leading to success.
- Develop and build the cGMP-manufacturing and process development functions and capability.
- Identify, recruit and manage a highly skilled team to accomplish both manufacturing and process development specializing in OV processes.
- Lead the development of CMC strategies, capabilities for OV’s and execution of Vyriad’s OV programs:
- Direction of upstream, downstream and formulation development activities to ensure scalable and commercially viable processes are developed.
- Responsible for all aspects of process scale up, technology transfer and GMP manufacturing.
- Ensure process development group best practices that are aligned with current GxPs.
- Author CMC sections of regulatory filings (IND, NDA’s, annual updates).
- Support management of supply chain of critical materials to ensure timely and cost-effective delivery.
Experience and Qualifications
- Advanced degree (PhD highly desirable) in relevant scientific discipline (such as Life Sciences, Biochemical engineering, Immunology, Molecular Biology, Biochemistry).
- At least 8+ years of experience in industrial process development or manufacturing.
- Biotech experience is required (cell and gene therapy, virology or biologics preferred).
- Understanding of upstream bioreactor production and downstream purification operations such as centrifugation, ultra-filtration and chromatography from pilot to GMP scale is required.
- Strong understanding of GxPs, process characterization/validation and technology transfer is required.
- Experience working in a regulated environment is a plus.
- Relevant experience in leadership and people management with successful performance track record.
- Ability to work independently as well as lead a cross-functional team to support corporate goals.
- Ability to adapt to frequent change and thrive in a dynamic and entrepreneurial early-stage environment.