Sr. Manager of Supply Chain Management
- Rezolute is a clinical-stage biopharmaceutical company developing novel therapies for diseases caused by chronic glucose imbalance.
- Rezolute has initiated a global Phase 2b trial in Europe for their lead clinical asset, RZ358, which is a potential treatment for Congenital hyperinsulinism (CHI), an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas.
- The company’s second clinical-stage asset, currently in Phase 1, RZ402, is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME)
- Rezolute has received orphan drug designation in the United States and European Union as well as a rare pediatric disease designation, for RZ358, enabling eligibility for a priority review voucher.
- More information can be found at rezolutebio.com.
Rezolute is seeking a Sr. Manager of Supply Chain Management for a portfolio of biologic and small-molecule products. The role will report to the Vice President of CMC and will have three primary areas of responsibility:
- Packaging, labeling and distribution of finished drug product for clinical and commercial use
- Management of inventories and shipping of drug substance, drug product and all critical supplies
- Supply/Production Planning for drug substance, drug product, finished drug product and critical supplies such as cell banks
The position is globally accountable for Production Planning and Inventory Management, Logistics & Distribution and Finished Drug Product Manufacturing for current and future clinical products for a fully outsourced supply chain. They will develop and executes long term strategies for supply chain setup and operations.
- Develops end-to-end supply plans for all products and manages the overall supply and inventory of drug substance, drug product, finished drug product and critical components (e.g., cell banks).
- Forecasts future manufacturing requirements required to support current and anticipated clinical trials. Assesses supply chain capacity and risks; drives the need for the identification of additional supply chain partners
- Responsible for shipment and storage of critical supplies, DS, DP and FDP.
- Evaluates and leads the selection of CMOs to support the packaging/labeling of multiple small molecule and antibody product candidates.
- Acts as primary supply chain interface with packaging/labeling CMOs. Responsible for establishing and managing the CMC scope-of-work and clinical supply agreements and other contractual arrangements
- In collaboration with Quality and the CMC team, responsible for managing timelines for FDP manufacturing and release for clinical use.
- Responsible for on-time delivery and release of adequate amounts Investigational drug product to clinical sites.
- Acts as the supply chain/FDP lead on global product teams.
- Lead facility fit assessments and process/facility gap assessments prior to GMP manufacturing
- Leads Technology Transfer and start-up activities at CMO’s and acts as the primary technical lead for cGMP packaging and labeling activities.
- Providing technical and scientific leadership as subject matter expert (SME) relating to technology transfers, manufacturing processes, complex deviations, technical troubleshooting, CAPA design and implementation, process monitoring, change control and process development and optimization
- Provides leadership and technical guidance for manufacturing investigations. Proposes remedial actions/plans consider both technical and business impacts. Presents proposed solutions and supporting technical data to internal and external stakeholders (including health authorities if required).
- Acts as person-in-plant and technical advisor during tech transfer, start-up, validation studies and manufacturing
- Develop, optimize and review Master Batch Records, test methods and product specifications prior to and during development and clinical manufacturing
- Defines phase-appropriate process and product characterization studies (e.g. shipping validation) throughout the product development lifecycle.
- Authors, reviews and approves technical reports.
- Authors and reviews relevant sections of regulatory submissions and dossiers (IND, NDA, IMPD etc.) including responses to Heath Authorities associated with submissions.
- Interfaces with global Health Authorities in support of regulatory submissions.
Qualifications/Requirements - We are looking for a candidate with:
- Bachelors degree in physical, biological sciences or engineering, supply chain management or related disciplines
- 5+ years of direct pharmaceutical/biopharmaceutical experience in clinical supply chain management, including cold chain products.
- Deep understanding of global biopharmaceutical supply chain processes, systems and applicable laws and regulations as well as solid business acumen. Proven track record of successfully managing clinical or commercial supply chains
- Direct experience with implementation product serialization regulations and best practices
- Experience leading cross-functional and/or departmental teams
- Experience leading projects with packaging and labeling CMOs; strong scientific and technical experience with equipment utilized in cGMP packaging and labeling facilities
- Direct experience with authoring and review of Module 3 CTD content; experience interfacing with international health authorities
- Comprehensive knowledge of current Good Manufacturing Practices (cGMPs) and multi-national regulations
- Ability to travel up to 20% of the time
Preferred Experience, Special Skills and Knowledge - We are looking for a candidate that is:
- Self-starter, with the ability to independently identify and resolve significant scopes of work with minimal oversight and direction.
- The ability to work effectively and lead small matrix and cross-functional teams in a fast-paced environment with a high level of urgency. Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams.
- Strong leadership skills and ability to effectively communicate up, down and across the organization
- Ability to effectively prioritize and deliver high-quality results on tight timelines
- Excellent written, verbal communication and presentation skills
- Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues
Interested and qualified candidates should send their resume to firstname.lastname@example.org to the attention of Melissa Quinn.