The SVP of CCS will be responsible for providing strategic leadership and direction to the business unit, ensuring operational excellence, financial growth, and a competitive edge in the cell and gene therapy market. The SVP will lead the organization to provide apheresis and manufacturing services to the sponsors of cutting-edge cell and gene therapies, working with clients in the biopharmaceutical and hospital sectors.

Strategic Leadership and Vision:

• Develop and execute the business unit’s long-term vision, strategy, and business plan, focusing on growth in the cell and gene therapy space.
• Stay ahead of industry trends, scientific advancements, and regulatory changes affecting CCS and biopharma industries.
• Ensure alignment with the Enterprise’s mission of providing top-tier draw-to-thaw services for cell and gene therapy customers.

Operational Excellence:

• Oversee CCS’ operations, ensuring the company delivers high-quality, scalable solutions for clients.
• Lead efforts and high-performing teams to continuously improve operational processes, efficiency, and compliance with regulatory standards (e.g., GMP, FDA, EMA), accrediting organizations (e.g., FACT) and industry best practices.
• Drive innovation in cell and gene therapy technologies, improving and adopting new development and manufacturing capabilities.

Client and Partner Relations:

• Build and maintain strong relationships with existing and potential clients, identifying opportunities for growth and collaboration.
• Ensure high client satisfaction through delivering products on time, maintaining quality standards, and optimizing client experience.
• Foster partnerships with key stakeholders in hospitals/institutions, biotech, pharmaceutical companies, industry associations, and regulatory bodies.

Financial Performance and Growth/Business Development:

• Develop financial, key performance indicators and business development strategies to drive growth, increase revenue, and optimize profitability while managing risk.
• Oversee budgeting, financial planning, pricing strategies, and forecasting, ensuring the business unit meets or exceeds revenue and EBITDA targets.
• Work with CEO and CFO to secure funding for expansion, technological advancements, and growth initiatives.

Regulatory and Quality Compliance:

• Ensure adherence to all regulatory requirements, including FDA, EMA, and other global and state health authorities, for the development and manufacturing of cell and gene therapies.
• Champion the implementation of robust quality systems and processes, maintaining the highest levels of compliance in manufacturing and clinical trials.

Team Leadership and Culture:

• Lead, mentor, and inspire the executive team and broader organization to perform at their best, fostering a culture of innovation, collaboration, and accountability.
• Build a high-performing, cross-functional team, attracting and retaining top talent in the fields of apheresis nursing, cell and gene therapy development, manufacturing, and regulatory compliance.
• Champion diversity, equity, and inclusion within the organization.
• Foster partnerships through NYBC and CCS to ensure the seamless delivery of services to customers, while coordinating timely use of G&A resources. 

Innovation and Technology Advancement:

• Drive the department’s process and analytical development efforts, encouraging innovation in cell and gene therapy technologies.
• Position the business unit as a leader in the rapidly evolving cell and gene therapy market by exploring emerging opportunities in advanced therapies and therapeutic apheresis.

Risk Management:

• Assess and manage the department’s risks, including operational, financial, regulatory, and market risks, ensuring that adequate safeguards are in place.
• Implement and oversee crisis management strategies, ensuring business continuity and resilience in response to unforeseen challenges.

Education:

• Advanced degree in life sciences, biotechnology, biochemistry or a related field.

Related Experience:

• Minimum of 15 years of senior leadership experience
• 3-5 years in an executive leadership role within a biotechnology, pharmaceutical, or CDMO environment.
• Proven track record in the development, manufacturing, and/or commercialization of cell and gene therapies.
• Experienced managing internal and external customers and stakeholders.

Travel:

• Ability to travel 25% to NYBCe locations.

Knowledge:

• Strong understanding of GMP, FDA/EMA regulations, and compliance frameworks in cell and gene therapy.

Skills:

• Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.
• Exceptional leadership and team-building skills, with the ability to inspire and manage diverse teams, including organized labor groups.
• Strong financial acumen, with experience in managing a P&L.
• Outstanding oral and written communication and interpersonal skills, with the ability to engage with clients, partners, investors, and regulatory bodies.
• Deep technical understanding of apheresis, cell and gene therapy development and manufacturing processes.

Abilities:

• Strategic thinker with the ability to execute and drive business growth in a highly competitive and regulated market.

For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $315,000.00p/yr. to $350,000.00p/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.