Associate Director, Operations
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 endpeople, processes, and plantwhile 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 disciplinesRequired Experience and Skills :
Minimum 8 years in a pharmaceutical backgroundMinimum 5 years in an operations management role including Management of diverse teams and activitiesExceptional people management skills with demonstrated success in hiring, developing, and scaling high-performing teamsPersuasive communication, stakeholder management, and organizational skillsExperience leading through change and building new organizational capabilitiesDemonstrated ability to motivate an organization around a common vision and deliver expected resultPharmaceutical & Biological process knowledgePreferred Experience and Skills :
Track record in facility start-up, tech transfer, and commercial manufacturingRelevant knowledge of GMP, aseptic processing, lyophilization, and regulatory expectationsStrong Analytical and decision-making skillsAnimal Health industry experience is preferredRequired Skills :
Aseptic FillingGMP OperationsLean Manufacturing OperationsManufacturingManufacturing OperationsOperations ManagementPeople ManagementPharmaceutical IndustryTeam LeadershipPreferred Skills :
Additional information about the role can be found in the full job description.The salary range for this role is $126,500.00 - $199,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https : / / jobs.merck.com / us / en / compensation-and-benefits .