[Hiring] Head of Global Product Supply @Rezolute

Role Description

A key member of Rezolute’s Technical Operations Leadership team, the Head of Global Product Supply has the mandate to provide the vision, leadership, strategy and management skills to build, lead and oversee the team’s transition from the development and supply of proprietary clinical stage programs to a fully externalized, globally enabled and integrated manufacture and supply team, supporting direct and partnered markets.

• Oversight over the company’s externalized manufacturing and supply chain platform, supporting the submission, approval, launch and supply of ersodetug, globally.
• Reports to the Head of Operations, collaborating daily with the Head of Quality, Clinical Operations, Commercial Leadership Team, Regulatory and the RZLT Management Team.
• Acts as a pivotal source of information for the Board of Directors.

Principle Duties and Responsibilities Include:

• Designing, developing and implementing the transition of the existing, clinically oriented functions toward a robust and reliable manufacturing and supply group.
• Maintaining agile operational capability while installing rigidity necessary to meet market demand through a fully externalized network of vendors.
• Partnering closely with the Head of Quality to deliver a unified, robust manufacture and supply platform.
• Accountable for the current Plan of Record, inclusive of late phase clinical supply supporting two Phase 3 pivotal (global) studies in rare disease.
• Providing oversight, leadership and management as needed to meet program milestones, manufacturing of drug substance, drug product and finished drug product.
• Continuously developing the manufacturing and supply chain operation and teams to ensure robustness and reliability of supply.
• Rebuilding the clinical supply chain through hiring or key resource, definition and deployment of process and procedure.
• Working closely with Quality, Clinical Operations, Regulatory and Finance to sustain a dynamic clinical supply program.
• Accountable for all externalized manufacturing, shipping, distribution, labeling, packaging and storage via a global network of qualified vendors.
• Developing strategy, tactics and deliverables for establishment of global supply of ERSODETUG for multiple indications.
• Identifying and mitigating risks to the supply of product to the clinical and/or global markets.
• Leading a team to collaboratively resolve deviations and investigations, enabling on-time reliable supply.
• Partnering with key functions to establish and sustain an S&OP process.
• Working cross functionally to identify product lifecycle needs.
• Applying suitable governance structure with external suppliers.
• Supporting global submissions in concert with Quality and Regulatory teams.

Qualifications

• B.S. is required.
• Commercial launch experience required.
• Biologics experience required.
• 20 Yrs+ in progressive Manufacturing and Supply Chain leadership roles within Lifesciences Start-up/Biotech organizations; Rare Disease experience preferred.
• Track record of establishing a global commercial product supply chain.
• Successful interactions with regulatory agencies, demonstrated by timely global submissions and approvals.
• Comfort in leading through influence, acting with agility, leading problem solving and driving toward robust solutions.
• Strong communication skills demonstrated at all levels of the organization.
• Sense of humor and humility are essential.

Requirements

• Position may require morning, evening and/or weekend commitments.
• Position may require domestic and international travel (up to 50%).

Benefits

• Health Insurance (Medical / Dental / Vision).
• Disability, Life & Long-Term Care Insurance.
• Holiday Pay.
• Tracking Free Vacation Program.
• 401(k) Plan Match.
• Educational Assistance Benefit.
• Fitness Center Reimbursement.