Senior Director, Apheresis Operations

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role:

ElevateBio is actively seeking an accomplished Senior Director to champion the advancement and oversight of our Apheresis Operations function. This pivotal role offers a transformative opportunity to both establish and elevate this function to a position of industry prominence. Reporting directly to the Senior Vice President of Global Supply Chain, this role involves fostering close collaboration with cross-functional teams, ensuring fulfillment of client contractual obligations, and actively contributing to the strategic development of our apheresis operations program.

Join us in shaping the future of groundbreaking medical advancements and making a lasting impact on global healthcare.

Here’s What You’ll Do:

Apheresis Operations:

• Collaborate with the Sr. VP, Global Supply Chain, or designee, to oversee administrative and operational aspects of the Apheresis Operations function.
• Support clients by conducting site assessments, developing strategic plans, and ensuring contractual obligations are met.
• Provide apheresis expertise for internal activities such as regulatory submissions, protocol development, and quality processes.
• Partner with clinical operations, quality assurance, supply chain, and commercial teams to build a sustainable collection network, including site selection, technical assessments, training, and onsite support.
• Contribute to the development and maintenance of procedures related to the functions of the apheresis operations department.
• Escalate and address apheresis quality issues, initiate deviations, and assist with investigations and resolutions.
• Monitor collection data for trends, key performance indicators (KPIs), and drive continuous improvement in site performance.
• Stay updated on local and international regulatory requirements, as well as the latest collection and preservation techniques.

Business Unit:

• Assist in developing and executing the Apheresis Operations marketing strategy.
• Collaborate cross-functionally to define contractual Statements of Work (SOW) and contract amendments.
• Explore opportunities to increase the client base and expand existing service offerings.
• Develop and execute internal/external apheresis awareness programs.

Requirements:

• Bachelor’s degree in nursing (registered nurse), master’s degree preferred.
• Significant experience within the biotech industry, particularly with cell and gene therapy products.
• Strong direct apheresis experience within the past 5 years, emphasizing progenitor and mononuclear cell collection.
• Experience working with clinical research teams.
• Strong organizational skills and the ability to function independently while managing site operations, documentation requirements, and contracts.
• Good understanding of applicable regulations and standards (AABB, FDA, FACT/JACIE, GxP).
• Flexibility to adapt to changing situations and prioritize tasks according to objectives.
• Excellent presentation skills and proficiency in IT tools (PowerPoint, Project Management, Word, Excel, etc.).
• Outstanding interpersonal skills with the ability to motivate others, influence, and negotiate conflicting situations.
• Effective decision making, priority setting and delegation skills.
• Effective teaching, training, planning and problem-solving abilities.
• May require up to 60% travel (domestically and potentially internationally).
• Technical training expertise.

 

Why Join ElevateBio?

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

We aim to be the dominant engine inside the world’s greatest scien