Director/Sr. Director, Reagent Operations

SUMMARY:

The Director/Sr. Director, Reagent Operations will lead and manage reagent manufacturing operations, worldwide distribution and positioning of products across Cytek facilities and distribution centers and ensure successful execution of commercial & operations reagent strategies. This individual will be responsible for sufficient, consistent, high-quality reagent production and distribution to meet market demand; transforming reagent operations to support min 50%+ increase in global segment annual revenues.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

To perform this job successfully, an individual must be able to perform essential duties and responsibilities satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Lead, direct and monitor every aspect of reagent production (catalog, clinical, and customs) with strong cross-functional leadership and across two manufacturing sites globally.
• Build reagent operations strategy and roadmap including required capex, facilities strategy, organization, IT systems, regulatory impact, and business processes
• Supervise manufacturing planning, scheduling, quality adherence, processing, materials management, and packaging.
• Optimize production/manufacturing performance through transparent KPIs and a culture of continuous improvement, significantly reduce order fulfillment lead times to achieve and maintain best in class service levels of (SLAs) <24hrs, optimize and reduce costs min of 5% year over year.
• Balance demand load across two manufacturing sites, ensures production schedules and support activities are aligned, effective planning and allocation of resources to meet demand with minimal scrap; ensuring high shelf life remaining on ready for sale products.
• Design and own an effective S&OP process to ensure product availability with adequate shelf life across all Cytek global locations - ensuring best in class order fulfillment performance
• Assess, develop and execute business strategies and practices to constantly improve production capability, production capacity, quality, costs and customer satisfaction.
• Hire, prepare, lead and retain fully engaged, talented workforce and ensure strong performance management and succession planning
• Develop and supervise annual manufacturing budgets and build factory capacity models
• Close collaboration with Reagent R&D team to facilitate and enable smooth transition of new products launches into manufacturing processes
• Close integration and collaboration with other leaders for support with supply chain, procurement, and logistics
• Comply with company policy and Standard Operating Procedures (SOPs)
• Ensure compliance with ISO13485, successful annual audits and recertifications
• Ensures production processes are adequately developed, documented, and performed in compliance with company procedures and external regulatory requirements.
• Other duties as assigned

REQUIREMENTS & QUALIFICATIONS:


The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelor's degree in business management, engineering or technology related field, advanced degree or MBA preferred
• 7-10+ years of progressive management experience in reagent manufacturing and development in various levels
• Experience working in a medical device regulated market. Preferably with flow cytometry instrumentation and reagents, but other diagnostic systems background will be considered (QSR, CE-IVDR, cFDA, ISO13485, ISO14971)
• Excellent computer skills including Microsoft office and experience in using business management software (NetSuite preferred)
• Excel at working across multiple departments and multiple global sites
• Data-driven, knowledge and decision making through operational metrics and analytics
• Six Sigma Green Belt (Black Belt preferred) or Kaizen engineer or Lean Six Sigma certified

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Prolonged periods sitting at a desk and working on a computer
• Must be able to travel up to 20%
• Must be able to lift up to 20 pounds

ADDITIONAL SKILLS AND COMPETENCIES :

• Excellent time-management
• Able to delegate tasks and implement changes appropriately and effectively
• Outstanding communicator, both orally and written
• Exceptional problem-solving skills
• Confident and effective decision-making skills
• Works well with a diverse range of people
• Fantastic motivator
• Strong business acuity with solid knowledge of finance, supply chain distribution and employee management
• Strong influencing and negotiation skills
• Diligent and proactive results-driven personality
• Ability to coordinate, plan, manage and oversee many aspects of a company for optimum productivity

Cytek is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, sexual orientation, national origin, genetic information, disability status, veteran status, or any other characteristic protected by law.