Director of Vector Engineering and Manufacturing Quality - Cell Therapy

Weill Cornell Medical College•New York, NY

About The Position

The Director of Vector Engineering and Manufacturing Quality will provide strategic, scientific, and operational leadership for gene delivery platforms and quality systems supporting ex vivo and in vivo cell therapy programs, with a strong emphasis on T-cell–based therapies. This individual will lead vector technology development; contribute strategically to T-cell engineering process development and manufacturing strategy; and oversee manufacturing quality to enable efficient translation of innovative genetic engineering approaches into IND-ready clinical products. The Director will oversee vector design, manufacturing, analytics, quality systems, and regulatory strategy for programs utilizing viral vectors (e.g. lentivirus, γ-retrovirus, AAV) and non-viral gene delivery platforms (e.g. transposons, LNPs, CRISPR). The role will be central to building robust, FDA-accepted CMC packages, managing internal GMP capabilities and external CDMO partnerships, and ensuring compliance with global regulatory standards. This position requires close collaboration with translational researchers, clinical investigators, regulatory affairs, manufacturing, institutional leadership, and external commercial and academic partners.

Requirements

PhD (or equivalent advanced degree) in molecular biology, bioengineering, immunology, gene therapy, or a related field. Exceptions for equivalent experience: Minimum of twelve (12) years with BS/BA; ten (10) years with MS/MA in lieu of PhD.
Minimum of 8-12 years (depending on degree) in clinical manufacturing, technology transfer, vector process development, and GMP operations for gene and cell therapy products.
Extensive hands-on experience in vector process development and engineering, including in-depth expertise across Lentiviral Vectors (LVV), γ-Retroviral Vectors (RVV), Adeno-Associated Viruses (AAV), Lipid Nanoparticles (LNPs), and other viral/non-viral vector technologies.
Proven track record in gene therapy and cell therapy development, with deep expertise in vector engineering(design, optimization, and scale-up) and quality systems (including impurity control, stability, and release testing).
Demonstrated success leading IND-enabling activities, CMC authorship, and regulatory interactions with FDA, EMA, and international agencies.
GMP and Regulatory Expertise: Strong understanding of cGMP regulations and compliance in a manufacturing environment, including aseptic processing, clinical product manufacturing, and global regulatory frameworks (ICH, FDA, EMA).
Proven leadership managing cross-functional teams, CDMO/CMO partnerships, and complex translational programs from process development through clinical supply.

Nice To Haves

Experience supporting T-cell-based immunotherapies (e.g., CAR-T, TCR-T) strongly preferred.

Responsibilities

Provide strategic direction for vector and gene delivery platform selection, construct design, manufacturing approaches, and analytical testing strategies to support novel IND applications.
Contribute to technology design and strategy for ex vivo and in vivo T-cell therapy, including next-generation CAR, TCR, gene-edited, and immune-modulatory platforms.
Drive innovation in gene delivery modalities (lentivirus, γ-retrovirus, AAV, CRISPR, transposons, LNPs) to improve efficiency, scalability, product quality, and clinical feasibility.
Develop and execute phase-appropriate vector and cell therapy process development strategies aligned with scientific, clinical, and regulatory goals.
Design and oversee experiments to optimize production processes.
Guide technology transfer from research to GMP manufacturing with rigorous process development, documentation, and standardization.
Lead the development and implementation of in-house GMP vector manufacturing capabilities, when this will be opportune, in a robust, cost-effective manner. Identify suppliers and negotiate agreements for starting material required for vector manufacturing.
Provide expert leadership in GMP process validation and manufacturing readiness for vector and cell therapy products.
Establish and oversee comprehensive quality control and analytical testing programs to characterize vectors and cell therapy products.
Lead development and qualification of assays supporting release testing, stability, comparability, and Certificates of Analysis. Ensure full compliance with quality system requirements and applicable regulations.
Author and oversee CMC sections for IND submissions, protocol amendments, and annual reports. Lead responses to FDA and global regulatory authority inquiries (written and in-person/virtual RFIs). Provide strategic regulatory guidance across programs.
Lead, mentor, and develop a multidisciplinary team of scientists, engineers, and technical specialists in vector engineering, manufacturing, and quality.