Director of Operations

Role Summary

The Director of Operations is an exempt level position working within Technical Operations. This individual will be responsible for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile cGMP environment.

Responsibilities

• Oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements.
• Lead a 250+ organization responsible for either the non-sterile or sterile manufacturing processes in a 24/7 operation and be responsible to assign personnel to execute daily production schedules.
• Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.
• Oversee the hiring, development, and performance management of staff in a growing operation in terms of volume/output and team size.
• Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will range from employee engagement, safe behavior, quality performance (right first time), schedule adherence, and productivity improvements.
• Support manufacturing investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections.
• Lead facility operating review meetings and sponsor various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.
• Support organizational design updates, operations organization build, operations ramp-up of commercial and clinical capacity.
• Build strong partnerships with Manufacturing, Supply Chain, Engineering, MS&T, and Quality to ensure seamless execution of daily production schedules.
• The role will require proven leadership to drive effective communication, coordination, and collaboration across relevant cross functional groups to ensure robust production, testing and release of product to patients.
• Serve as the delegate for the Head of Operations.
• Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the organization.

Qualifications

• Bachelor‚Äôs degree in Engineering, Life Sciences, or related field (required).
• Advanced degree (MS, MBA, or PhD) preferred.
• Minimally 12+ years of combined experience in commercial scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference for Cell/Gene Therapy experience.
• Minimum of 5 years of experience of progressive leadership roles in a cGMP operation, with prior Biologics and/or cell therapy operations experience preferred.
• Prior experience leading large multilevel teams.
• A history of developing and building cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning.
• Communicates effectively with people at all levels, including the ability to understand their priorities, and to earn their respect and trust, along with the willingness to provide them with the best decisions in time-sensitive situations.
• Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels.
• Experience in a growth environment managing the fast pace of change, balancing day to day operational demands with the need to extend and improve the planning horizon to prepare for tomorrow.
• Track record of successfully leading audits and inspections (FDA, EMA, etc.).
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
• Clear and succinct verbal and written communication skills.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Project management skills, responsiveness to issues, and demonstrated passion for creating new medicines.
• Leadership & People Management: Proven ability to lead cross-functional teams, manage performance, and develop talent. Ability to create an engaged workforce.
• GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.
• Operational Excellence: Expertise in Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
• Strategic Planning: Experience in setting and executing long-term operational strategies aligned with business goals.
• Budget & Resource Management: Strong financial acumen with experience managing budgets, forecasts, and headcount planning.
• Risk Management: Ability to identify, assess, and mitigate operational and compliance risks.
• Technology & Automation: Familiarity with modern manufacturing systems (MES, ERP, etc.) and digital transformation initiatives.

The anticipated base pay range is: $187,989 USD - $246,735 USD