Director/Sr. Director of CMC Cell Therapy - Invectys

Company: BioHouston
Location: Houston
Posted on: March 19, 2023

Job Description:

Invectys, headquartered in Houston, Texas, is a clinical stage cell immunotherapy company focused on the development of innovative approaches to treat cancers by exploiting novel approaches to mobilizing and restoring the anti-tumor capacity of the immune system of cancer patients.CMC level expert on process development with GMP manufacturing experience who can guide internal team or manage/lead outsourced CDMOs. Duties and requirements include but are not limited to the following:

• Subject matter expert in CART cell therapy product design, process development and manufacturing in support of CMC.
• Lead cell therapy process development and characterization activities
• Provide technical and GMP compliance guidance to cross-functional teams in support of project goals
• Establish, communicate, and manage project plans and timelines for phase-appropriate process development, transfer to manufacturing and manage activities through to punctually achieving goals
• Comprehensive knowledge of cell therapy (CART. CAR-NK, CAR-----T) , process development, process characterization, process monitoring, process control strategy, technical transfer, as well as GxP regulations, guidance, and industry best practice.
• Proven record in the successful leadership of technology development projects and deployment of new technologies and systems into GMP operations.
• Demonstrate in-depth skills in designing, executing and interpreting experiments
• Experience authoring CMC sections and interacting with global heath authorities
• Excellent interpersonal, verbal, written and presentation skills.
• Leadership experience in managing multiple stakeholders (internal team and external CRO/CMOs), prioritizing responsibilities, and allocating resources to maximize results.Comfortable in a fast-paced startup environment with can-do attitude and ability to work in a highly matrixed and dynamic business environment and ability to be agile when adjusting workload based on changing priorities.Interested candidates should send their resume to Rosie Williams, VP of Administration and Controller: rosie.williams@invectys.com

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