Director of Vector Engineering and Manufacturing Quality - Cell Therapy

Lensa is a career site that helps job seekers find great jobs in the US. We are not a staffing firm or agency. Lensa does not hire directly for these jobs, but promotes jobs on LinkedIn on behalf of its direct clients, recruitment ad agencies, and marketing partners. Lensa partners with DirectEmployers to promote this job for Weill Cornell Medical College. Clicking "Apply Now" or "Read more" on Lensa redirects you to the job board/employer site. Any information collected there is subject to their terms and privacy notice.

Title: Director of Vector Engineering and Manufacturing Quality - Cell Therapy

Location: Upper East Side

Org Unit: MCC Laboratories

Work Days: Monday-Friday

Weekly Hours: 35.00

Exemption Status: Exempt

Salary Range: $273,300.00 - $336,300.00

• As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices

Position Summary

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, ?-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.

Job 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, ?-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.

Education

• 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.

Experience

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

Knowledge, Skills And Abilities

• 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.

Licenses and Certifications

Working Conditions/Physical Demands

Cornell welcomes students, faculty, and staff with diverse backgrounds from across the globe to pursue world-class education and career opportunities, to further the founding principle of "any person, any study." No person shall be denied employment on the basis of any legally protected status or subjected to prohibited discrimination involving, but not limited to, such factors as race, ethnic or national origin, citizenship and immigration status, color, sex, pregnancy or pregnancy-related conditions, age, creed, religion, actual or perceived disability (including persons associated with such a person), arrest and/or conviction record, military or veteran status, sexual orientation, gender expression and/or identity, an individual's genetic information, domestic violence victim status, familial status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Cornell University embraces diversity in its workforce and seeks job candidates who will contribute to a climate that supports students, faculty, and staff of all identities and backgrounds. We hire based on merit, and encourage people from historically underrepresented and/or marginalized identities to apply. Consistent with federal law, Cornell engages in affirmative action in employment for qualified protected veterans as defined in the Vietnam Era Veterans' Readjustment Assistance Act (VEVRRA) and qualified individuals with disabilities under Section 503 of the Rehabilitation Act. We also recognize a lawful preference in employment practices for Native Americans living on or near Indian reservations in accordance with applicable law.

If you have questions about this posting, please contact [email protected]