Director, Operations - Cell and Gene Therapy (US East Coast)

Description

Title : Director, Operations - Cell and Gene Therapy, Global Operations and Control Tower Advanced Therapy Division Job Purpose : Responsible for the strategic oversight and management of key activities related to the Advanced Therapy Division Global Operations Team and Global Control Tower Teams.

This position includes oversight of our packaging systems including liquid nitrogen (LN2), dry ice, and the network expansion surrounding the filling and storage capabilities.

In addition, a key responsibility will be to optimize lane mapping and feasibility, risk assessments, and to establish processes and relationships with air and ground freight providers.

On the control tower side, fastidious adherence to the highest standards of global track and trace, best practices with respect to the use of data loggers, and real-time visibility will be paramount.

People management as well as client-facing experience are essential. Additional responsibilities include full P&L ownership, operational service delivery and quality, client relationships and key account management, operational excellence and optimization.

Main Duties and Responsibilities : Responsibility for both strategic and tactical day-to-day management of the business, overseeing operational logistics, leading the operational team and also the global control tower, developing client relationships and sales growth and delivering excellent service standards.

On a strategic level, work closely with peers and regional management team to deliver process improvement and operational change.

Ensure high quality work through clear leadership and motivating team to deliver high performance and growth. Also assist in developing strategies and tactics for improving operation efficiencies for global harmonization.

The role has full accountability for P&L. The position will report directly to the Senior Director, Global Cell & Gene Therapy Operations, NORAM. Duties and Responsibilities

Reporting to the Senior Director of Operations, this person will be responsible for successfully overseeing the daily operations and control tower responsibility of the Advanced Therapy Division shipments globally.

This will include the daily co-ordination with various branches and close monitoring of our Maestro system

• Responsible for Marken's global advanced therapy division packaging solutions, with a focus on LN2 and dry ice capabilities, strategic capability expansion, lean inventory management and maintenance, and personnel and capital expenditure, operational excellence
• Develop excellent working relationships with internal departments Project Management, Operations, Control Tower, Branch Operations, Commercial, Regulatory, Customer Relationship Managers, Overseas Marken offices / agents and the Customer Services Team as well as external providers (outside service providers)
• Responsible for ensuring compliance on training requirements for new and existing team members within his / her function
• Directs strategic projects (e.g. facility build outs) and develops appropriate critical path schedules ensuring consensus of milestone dates consistent with business and client expectations and drives program completion in a timely manner
• Acts as a regional and global escalation contact both internally and externally
• Attends client review calls, bid defenses, and attends and leads client meetings with additional responsibility to present at conference / trade show meetings, where approved / applicable
• Oversees an operational team responsible for lane mapping, LN2 inventory management, feasibility and risk assessments and regularly ensures the successful day-to-day track and trace and monitoring of live shipments in Maestro against client specifications and in strict adherence to this pre-defined lane mapping, with updates made on a regular schedule.
• Ensures branches and OSPs follow the collection and delivery instructions per agreed client operating procedures and driver instructions.
• Helps set up paperwork or checklists associated with ATD / cell and gene therapy shipments.
• Provides support and assistance when dealing with special requirements and inform internal teams where required
• Manages own priorities, maintain metrics and analyze data to assess performance and implement improvements
• Identify project barriers (resource constraints, capability gaps) and works with both the Global Operations Team Leads and the Global Control Tower Managers to resolve issues expeditiously
• Assists in the identification and implementation of continuous improvement opportunities and customer satisfaction opportunities

Other key responsibilities :

• Growing the business, client base, accounts and strategic relationships
• Delivering exceptional services of the highest quality
• Satisfying and building loyalty with our clients
• Performing in full compliance with regulatory (e.g. GDP, TSA, IATA DG, etc.) and Company requirements
• Delivering financial results at, or better than, approved budgets, and balancing the operational costs and bought-in-services with revenue targets.
• Identifies financial efficiencies with OSPs, packaging, and other cost categories
• Achieving operational excellence by continually improving operational performance (quality, delivery, productivity, cost effectiveness)
• Managing third parties (local agents, airlines, suppliers, ground freight providers, driver excellence, etc) to ensure compliance with all Marken and regulatory requirements and expectations.
• Reporting operational and financial status accurately and in a timely manner
• Motivating, managing and developing staff individually and collectively as a high performing team
• Ensuring safe / healthy / environmentally responsible facilities, operations and staff conditions
• Developing and implementing strategic plans in cooperation with the NORAM Logistics and Marken global leadership teams
• Maximizing shareholder value in line with Marken’s strategic business plan
• Contributing to corporate initiatives and sharing / incorporating network best practice
• Creating innovative and commercially unique offerings to increase Marken’s value to our clients

Experience :

• Subject matter expert in cold chain logistics relating to advanced therapy medicinal products (ATMPs), with particular emphasis on cell and gene therapy and nucleic acid therapy products
• 24 / 7 / 365 global control tower or customer service experience in the management and track & trace of cold chain shipments with a focus on life-critical medicinal products
• Operations, customer service, and / or commercial experience in healthcare supply chain / services / logistics
• Experience in leading a global control tower and / or customer service team function, with live real-time track and trace
• Effective people and project leader, line leadership experience, with P&L experience.
• Ability to build strong relationships with strategic customers and internal stakeholders
• Leading and delivering operational improvements resulting in increased performance levels and profitability

Competencies :

• Results orientation
• Team leadership
• Financial acumen
• Collaboration and influencing
• Tactical execution
• Strategic thinking
• Unquestionable character and integrity

Qualifications :

• Bachelor's degree (preferred post-graduate degree Master's, Ph.D) with minimum 10-15 years’ experience in logistics operations, ideally with both logistics and storage management experience, with 5-10 years' experience in a healthcare-related industry
• Experience in the shipment, storage, and management of advanced therapy division shipments, with particular emphasiss on cell and gene and nucleic acid (e.g. mRNA) therapies
• P&L or cost center experience essential
• Specialist courier experience desirable, with effective management of OSPs both in air and ground freight
• Lean / Sigma mindset with a certification or experience preferred
• Customer facing and contract management experience preferred
• GMP, GDP and GDocP guidelines awareness and experience is preferred

Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.

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