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The NYBC Haplobank Director is responsible for the oversight of management and operational direction of the NYBC Haplobank iPSC cell line biorepository. This position involves overseeing the production, storage, quality control, and distribution of induced pluripotent stem cell (iPSC) lines under cGMP conditions to researchers and scientists worldwide. The Haplobank Director plays a critical role in maintaining the integrity and usability of the cell line collection, ensuring compliance with relevant regulations, and participating in collaborations with external organizations.

The Director will play a vital role in advancing scientific research by ensuring the availability and quality of valuable cell lines for external researchers. Expertise with iPSCs is vital to the successful candidate and will contribute to the repository's growth, impact, and reputation within the scientific community.

Reports To: NYBC Chief Scientific Officer (CSO)

Primary Functions:

Leadership: Implement goals for the iPSC Haplobank cell line repository, aligning with the organization's mission and objectives as defined by organization leadership. Provide oversight and guidance to the repository staff, fostering a collaborative and innovative work environment.
• Collection Management: Oversee donor cord blood isolation of CD34 cells, transcriptional reprogramming of CD34+ cells to iPSCs, QA and QC validation of iPSC clones for cell seed stock cryopreservation, and documentation of iPSC cell lines manufacturing under cGMP conditions. Ensure compliance with legal, ethical, and regulatory requirements for obtaining and distributing cell lines.
• Quality Control: Assist in the development and implementation of rigorous quality control procedures to ensure the accuracy, authenticity, and viability of the cell lines within the repository. Establish protocols for regular cell line authentication, mycoplasma testing, and other relevant quality assurance measures.
• Regulatory Compliance: Stay up-to-date with relevant regulations and guidelines pertaining to the handling, storage, and distribution of cell lines. Ensure compliance with ethical guidelines, bio-safety regulations, and data protection laws. Collaborate with legal and compliance teams to address any regulatory issues and maintain required documentation.
• Distribution and Access: Develop policies and procedures for cell line distribution to researchers and scientists worldwide. Establish a streamlined request and review process to facilitate efficient and equitable access to cell lines, while considering intellectual property and licensing requirements.
• Supporting Functions.
• Repository Operations: Assist with management of day-to-day operations of the cell line repository, including maintenance of a comprehensive database, inventory management, and tracking systems. Ensure efficient and secure storage of cell lines, adhering to best practices for cryopreservation and long-term storage.
• Collaboration and Outreach: Foster collaborations and partnerships with academic institutions, research organizations, and industry stakeholders to expand the repository's cell line collection and enhance its visibility within the scientific community. Represent the repository at conferences, workshops, and other relevant events to promote its services and establish relationships with potential collaborators.
• Budget and Resource Management: Develop and manage the repository's budget, ensuring effective allocation of resources for procurement, equipment maintenance, staffing, and operational expenses. Seek funding opportunities and grants to support the repository's growth and sustainability.

Education:

• A Ph.D. or equivalent degree in a relevant field of life sciences, such as cell biology, genetics, or molecular biology.

Experience:

• Managerial experience required.
• 10 or more years of extensive experience with iPSC biology and tissue culturing is required.
• 4+ years should include working experience in iPSC production or cell manufacturing space.
• Experience with ISO-7 clean room function and cGMP manufacturing practices is a plus
• Experience with cell line repository management, including knowledge of best practices, quality control measures, and regulatory requirements is preferred.

Licenses / Certifications

• cGxP or ISO Certification as necessary.

Knowledge:

• Expert knowledge of cGTP and cGMP management practices, manufacture and storage of hematopoietic progenitor cell products, including product release criteria and cold chain storage and shipment.
• Experience in Sendai viral reprogramming.
• Knowledge of directed differentiation techniques.

Skills & Abilities:

• Strong leadership and managerial skills, with the ability to motivate and inspire a diverse team.
• Excellent organizational and project management skills, with the ability to prioritize tasks and meet deadlines.
• In-depth understanding of cell line authentication techniques, cryopreservation methods, and long-term storage protocols.

For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $180,000.00 p/yr to $195,000.00 p/yr. For applicants who will perform this position outside of New York City or Westchester County, salary will reflect local market rates and be commensurate with the applicant's skills, job-related knowledge, and experience.