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Open nowPosted 67 days ago

Head of Global Product Supply

rezolutebio9 open roles

Where
Redwood City
Work mode
Remote
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Your applicationOpen nowHead of Global Product Supplyrezolutebio · Redwood City

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This job: posted 67 days ago

The posting

Company Description

Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI)

Position Description

Overview

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. In particular, the Head of Global Product Supply will have oversight over the company’s externalized manufacturing and supply chain platform, supporting the submission, approval, launch and supply of ersodetug, globally. The position reports to the Head of Operations, working daily in collaboration with the Head of Quality, Clinical Operations, Commercial Leadership Team, Regulatory and the RZLT Management Team, while acting as a pivotal source of information for the Board of Directors.

Principle Duties and Responsibilities Include:

  • 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 all externalized manufacturing, shipping, distribution, labeling, packaging and storage, via a global network of qualified vendors; Responsible for the processes utilized by Rezolute to manage and oversee vendor readiness and execution to ensure Right First Time, On Time In Full supply to clinical and commercial supply chains.
  • 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.

Areas of specific responsibility include:

  • 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.

Qualifications/Requirements - We are seeking a candidate with:

  • B.S. is required
  • 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%)

Rezolute (RZLT) currently anticipates the base salary for the Head of Global Product Supply role could range from $290,000 to $340,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience, and geographical location of the selected candidate.

Qualifying employees are eligible to participate in benefit programs such as:

  • 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

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.

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