Associate Director, Operations

Job Description

Join us as the Associate Director, Operations and lead the successful start-up and long-term operation of our state-of-the-art new biopharmaceutical facility in Desoto, KS. You will build GMP-compliant operations end to end—people, processes, and plant—while driving cross-functional execution. This is an ideal role for an operational leader with proven past performance with facility start up and operational readiness, deep quality and USDA regulatory expertise and technical operations mastery. 

People leadership and culture-building  are vital (hiring, training, standard work, tiered daily management), financial acumen (budget, COGS), and continuous improvement (lean, OEE, CAPA effectiveness) to achieve right-first-time, safe, and reliable supply. You will play a pivotal role in establishing a culture of safety, quality, and continuous improvement, ensuring compliance with regulatory standards.

Responsibilities include but are not limited to:

Facility Start-Up & Operational Readiness

• Lead end-to-end operating readiness for a new biopharmaceutical facility,
• Partner with Engineering, Quality, and Supply Chain to ensure seamless facility commissioning and handover into operations.
• Define and implement standard operating procedures, batch records, and operational processes in alignment with GMP requirements.

Team Development & Leadership

• Recruit, hire, and develop a diverse and high-performing operations team
• Build a culture of accountability, collaboration, and employee engagement.
• Implement structured training programs to ensure technical excellence and regulatory compliance.
• Provide strategic direction and leadership for aseptic filling, lyophilization, and other core manufacturing operations.
• Ensure manufacturing goals are met for safety, quality, supply, cost, and compliance.
• Champion operational excellence, lean principles, and continuous improvement initiatives.

Regulatory Compliance & Quality

• ​Establish and maintain GMP-compliant operations, adhering to USDA and other global regulatory requirements.
• Lead preparation and successful execution of regulatory inspections and audits and audit responses.
• Partner with Quality to implement a robust quality management system.
• Ensure a safe, compliant, inclusive work environment

Strategic Leadership

• ​Contribute to long-term manufacturing strategy and capacity planning.
• Drive alignment between site operations and global business objectives.
• Builds annual budget and manages successful delivery of spend depreciation, transfers to meet P&L and standard cost commitments.

Education:

• Bachelor's Degree in Biotechnology or relevant disciplines

Required Experience and Skills:

• Minimum 8 years in a pharmaceutical background
• Minimum 5 years in an operations management role including Management of diverse teams and activities.
• Exceptional people management skills with demonstrated success in hiring, developing, and scaling high-performing teams.
• Persuasive communication, stakeholder management, and organizational skills.
• Experience leading through change and building new organizational capabilities.
• Demonstrated ability to motivate an organization around a common vision and deliver expected result
• Pharmaceutical & Biological process knowledge

Preferred Experience and Skills

• Track record in facility start-up, tech