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Director, Manufacturing Outsourcing


This is a Full-time position in Gainesville, FL posted October 17, 2021.

The Director of Manufacturing Outsourcing is a leadership position within AGTC’s Outsourcing team.

Director of Manufacturing Outsourcing position will build, lead, and manage the Manufacturing Contracting function, with responsibility for clinical development supplier management and site contracts, budgets and payments.

This position will work with other Manufacturing team members, clinical research suppliers, Finance, Regulatory, Quality Assurance and others to ensure the successful, cost-effective, and timely execution of AGTC manufacturing activities.

Reporting Relationship

• The Director of Manufacturing Outsourcing reports directly to the Senior Director of Outsourcing

Duties and Responsibilities

• Develop, lead and implement a manufacturing, packaging and supply chain outsourcing strategy

• Accountable for playing an integral role to key stakeholders for specific outsourcing strategies, tactics, and practices

• In collaboration with Tech Transfer Director and other management, facilitate external vendor selection when required, with a focus on CMC activities, to support manufacturing, tech transfer and logistical coordination aligned with departmental and corporate strategy

• Leads efforts to implement strategy and oversight for drug packaging and distribution

• Oversees contract management and review of all MSAs, SOWs, COs, related to CMC

• Evaluate and make recommendations on strategic decisions with significant impact to manufacturing network.

Examples include, but may not be limited to:

• Manufacturing strategic philosophies (for example, site missions based on integrated supply chains vs.

missions based on technology platforms)

• Manufacturing policies

• Capacity utilization, expansion, and rationalization

• Sourcing

• Make/buy – facilitates site selection process

• Mergers and acquisitions

• Identifies manufacturing opportunities, bottlenecks and synergies

• Provides recommendations and solutions including financial analysis and basic modeling

• Develop common procedures and systems for dissemination of key information across the manufacturing sites

• Provide oversight and support the yearly standard cost budgeting process for Manufacturing

• Drive strategic supplier management within CMC.

Deliver expected results such as holding quarterly reviews, managing to Service Level Agreements (SLAs) and Key Performance Indicators (KPIs), ultimately improving overall vendor performance

• Provide oversight and support the yearly standard cost budgeting process for Manufacturing, including accrual reporting and reforecasting

• Ensure consistent processes and practices in line with established outsourcing and company directives

Educational Qualifications

• Bachelor’s degree required

• Master’s degree or higher in business and/or health-related science or equivalent preferred

Additional Qualifications

• At least 10 years in-depth strategic and operational outsourcing experience with a solid working knowledge of category management

• At least seven (7) years overall business experience in contract manufacturing

• In-depth working experience with CMOs for Cell and Gene Manufacturing

• Proven experience in supply chain analysis and management for Cell and Gene Manufacturing

• Outstanding communication and project management capabilities

• Experience in positions of increasing analytical complexity, autonomy and responsibility.

• Demonstrated ability in organizing, analyzing and reporting complex financial data with solid grounding in basic procurement and financial processes and systems

• Change management and process improvement skills with direct experience in delivering business process change

• Strategic thinker with solid facilitation ability supported by excellent interpersonal competencies (communication, leadership, influencing)

• Proven capability in negotiation, conflict resolution and stakeholder management

• Experience managing direct reports

• Excellent organizational skills and attention to detail

• Effective communication and interpersonal skills

• Ability to efficiently perform multiple tasks and manage changing priorities

• Ability to build strong relationships with co-workers of various backgrounds and expertise

• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor

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