• Charged with designing, developing and implementing the transition of the existing, clinically oriented functions toward a robust and reliable manufacturing and supply group, positioned to support global markets. In this, the organization must maintain its agile operational capability while installing the rigidity necessary to meet market demand through use of a fully externalized network of vendors.  In this, the Head of Global Product Supply will partner closely with the Head of Quality to deliver a unified, robust manufacture and supply platform, suitable for scale of global supply.   

• Accountable for the current Plan of Record, inclusive of late phase clinical supply supporting two Phase 3 pivotal (global) studies in rare disease.   

Accountable for identification, implementation and maintenance of robust manufacturing, inventory management and supply systems 

Leads a team to collaboratively (Quality, MSAT and the Technical Operations Leadership) resolve deviations and investigations, enabling on-time reliable supply.  

Accountable for and partners with key functions (Commercial Ops, Market  Access, Patient Services, Finance) to establish and sustain an S&OP process, arriving at supply and demand models, COGs, and spend, to support clinical and commercial supply. 

Works cross functionally to identify product lifecycle needs, enabling feasibility, development and implementation in concert with product and corporate strategy. 

Applies suitable governance structure with external suppliers to drive at open, contemporaneous and clear understanding of conduct of work, costs, risks and deliverables. 

• Work as part of a broader Technical Operations Leadership team, striving for open, honest communication, and collaboration. 

• Supports global submissions in concert with Quality and Regulatory teams. 

• Build, lead, manage and develop a best-in-class, high-performance team and related support functions. Provide effective leadership to the organization to ensure the development of the business and its people.  

• Work diligently with the Head of Quality to ensure compliance of operation and procedure, supporting the Head of Quality with respect to registrational compliance evaluation, and ongoing release of drug. 

• Oversee functional efforts to optimize existing processes, scale-up efforts and solve complex manufacturing issues in a compliant and timely manner. 

• Responsible for assessing and analyzing information resulting in recommendations for long-term manufacturing solutions, including new manufacturing sites and facilities, that are aligned with the corporate strategy and evolving goals. 

• Support product launches by ensuring practical and cost-effective manufacturing and analytical approaches. 

• Ensure the management of all financial aspects of supply including budgeting, forecasting, long-range planning and overall management and accountability of product supply.  

• Regular interaction with CDMO(s) and MSAT support teams for continual process improvements. 

• Work collaboratively with Quality and Regulatory to oversee establishment of development stage and product appropriate specifications aligned with production capabilities. 

• Lead development of relationships and contracts for the procurement of high value and cost- effective services and materials for the company's products. Coordinate the selection and oversight of component vendors and contract manufacturers. Conduct project management and day-to-day interactions with all related research and contract manufacturing operations for clinical products. 

• Ensure all manufacturing agreements are effectively negotiated to meet the near and long term needs of Rezolute in a cost-efficient manner as agreed with legal, finance and functional heads. 

• Review technical documentation and summaries to ensure sound rationale, conformance with regulations and existing approvals, and challenge where appropriate the effectiveness of these documents to deliver on the intended purpose. 

• Commercial launch experience required 

• Biologics experience required 

• 20 Yrs+ in progressive Manufacturing and Supply Chain leadership roles within like Lifesciences Start-up/ Biotech organizations; Rare Disease experience preferred 

• They should have a track record of establishing a global commercial product supply chain and having had successful interactions with the regulatory agencies, as demonstrated by timely global submissions, approvals and clinical and commercial supply of pharmaceutical compounds, specifically biologics drugs. 

• Candidate should have comfort in leading through influence, acting with agility, leading problem solving and driving toward robust solutions; Communication is a critical strength, demonstrated at all levels of the organization; Sense of humor and humility are essential 

• Position may require /morning, evening and/or weekend commitments as the RZLT team is spread across the US, and vendors located offshore. 

• Position may require domestic and international travel (up to 50%)