Head of Supply Chain – FerGene – MA, USA
FerGene is a gene therapy company that’s committed to revolutionizing the treatment of bladder cancer through its innovative science and unparalleled commitment to patiet care. We are a privately held Boston-based biotech created through a joint partnership between Ferring Pharmaceuticals and Blackstone Life Sciences and we’re preparing to commercialize nadofaragene in the U.S. for high-grade, BCG-unresponsive non-muscle invasive bladder cancer.
Our team is comprised of passionate, driven and collaborative individuals who are united in their commitment to delivering a new standard of care to patients living with high-grade non-muscle invasive bladder cancer who are unresponsive to BCG – an area of critical unmet need. With its Phase 3 clinical development program underway, FerGene is building its commercial and medical Uro-Oncology team and is looking for candidates who share our passion and dedication to the Uro-Oncology community.
Leaders from top pharmaceutical companies from around the globe have joined the FerGene team, bringing a wealth of experience that will serve as the foundation for our innovative company. FerGene puts people first and reinforces its values based on Respect, Trust and Integrity. In addition, we also value Ownership, Excellence and Collaboration and are looking for candidates who model those behaviors every day.
Come be part of the future of gene-mediated immunotherapy advances.
A rare opportunity to join a highly dynamic, late-stage, biotech where you get the chance to be part of the foundational team that is commercializing the first gene therapy for bladder cancer.
We are seeking a Senior Director of Supply Chain to provide strategic direction, and oversight of all aspects of our commercial/clinical supply chain. This role will manage the supply chain for our lead program which has a PDUFA date of May 01st. Additionally, this individual will own the supply chain components related to our clinical development programs through collaboration with various functions including external CRO’s and CDMO’s.
This leader will establish and build the supply chain function working closely with Commercial, Clinical Operations, Technical Operations, Quality, Regulatory Affairs. This leader will ensure FerGene is well-positioned to meet development and commercial material/production needs. The position requires a goal-oriented individual who is a positive influence and role model that embraces change, possesses a continuous improvement mindset, and has the passion for exceeding company and customer expectations.
We see this role as one of the most important hires we will make as we look to scale the Technical Operations organization. This leader will be part of the Technical Operations Leadership Team reporting into the SVP of Technical Operations. The Head of Supply Chain’s ability to connect people, teams, and functions across the organization and with key external partners will be vital in driving commercial and clinical success.
- Department Build:
- Develop a team of world class supply professionals focused on delivering for patients, working with integrity and collaborating effectively
- Develops long-term strategies to establish and maintain a robust commercial supply chain, enact appropriate risk mitigation procedures, and monitor and identify future market trends
- Define, execute and lead strategic initiatives for supply chain forecasting and management, including cost reduction and risk reduction opportunities, inventory optimization and other activities related to warehousing of materials and materials management improvements (including but not limited to inventory management systems development).
- Partner with Commercial and Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, sales forecasts, launch planning to develop supply requirements plans.
- Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable
Production & Capacity Planning
- Drives the Sales & Operations Planning process including both Commercial/Clinical demand forecasting and production planning.
- Lead end to end supply chain business processes which include Demand Planning and Forecasting, Direct Material Procurement, Expediting, Supply Planning, Master Scheduling and Inventory Management.
- Develop user requirements and work cross functionally to implement an enterprise resource planning system
- Establish cold chain shipping, distribution, and trade strategy and processes
- Qualify logistics providers and set up the supply chain including courier selection, container validation, etc.
- Own the relationship with 3PL distributors and qualified external supply chain partners.
- Monitor inventory levels at depots/clinical sites through the life of a trial and/or commercial sales; take preventative actions to avoid potential supply issues
- Manage all drug product shipping, labeling and distribution to worldwide clinical sites/commercial sites using a network of vendors
- Coordinate shipments of in-process GMP materials and released clinical materials between vendors and storage sites
- Support country logistics for shipping and importation, on assigned study or program
- Anticipate risks and identify proactive measures to mitigate issues
- Establishes and maintains a system for managing supply of materials that includes specifying, purchasing, receiving, testing, releasing, and using materials
- Establishes and executes material planning procedures to ensure a consistent supply of materials to meet the production plan both near term and long range. The output of the materials plan includes planned purchases and production events (e.g. media & kits)
- Works with Purchasing and Quality to establish and maintain a reliable supplier network to provide the best value to FerGene
- Partner with quality to conduct risk assessment and supplier audit / qualification. Use risk based approach to determine preferred supplier and materials supply/inventory strategy
Sourcing and supply network strategy
- Leads sourcing and support overall operations strategies assessment include Make/buy evaluations, scenarios planning, supply impact assessment and network supply strategy
- Accountable for defining and reporting Supply Chain Performance Management
- Proactively identify, develop, and implement reporting and analytics to support the monitoring of overall supply chain performance
- Measure, trend and report supply related KPIs as a basis to drive continuous improvement
- BS or advanced degree in biology, chemistry, or engineering disciplines with a minimum of 15 years of relevant experience in biotech or pharmaceutical industries, ideally in a supply chain leadership role within the biotechnology or pharmaceutical industry; cell and gene therapy experience preferred
- Leadership experience with clinical and commercial supply chain development, manufacturing strategy development, establishing short and long-range operational and strategic plans, and delivering results within tight project deadlines
- Demonstrated ability to manage supplier relationships for clinical and commercial manufacturing, including relationship building, improvement of execution deliverables and contract negotiation
- Experience in overseeing manufacturing/labeling/packaging for global markets to support product launch and commercialization is required
- Strong familiarity with ERP systems, supply chain planning/management/optimization applications, and Lean concepts
- Proven understanding of global distribution requirements and industry best practices.
- Outstanding interpersonal verbal, written, and presentation skills in communication with internal and external colleagues and partners
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Strong leadership skills, including demonstrated ability to lead a cross-functional team, and to influence at all levels of an organization.
- Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.
- Available to travel both domestically and internationally up to 20%
Our ideal candidate will be able to demonstrate:
- Dealing with Ambiguity: The ability to thrive in a dynamic, rapidly changing environment, ability to lead initiatives with unclear answers/solutions.
- Strategic Thinking: The capacity for thinking conceptually, imaginatively, systematically and opportunistically with regard to the attainment of success in the future.
- Innovation: The ability to consistently demonstrate the following skills & behaviors:
- generates creative ideas;
- thinks critically through alternative approaches;
- seeks out new information and integrates what is essential from new data;
- evaluates future directions and risks based on current and future strengths, weaknesses, opportunities and threats
- Entrepreneurial Leadership: The ability to thrive in a fast-paced, dynamic environment, comfortable with ambiguity and able to carve through situations with unclear answers/solutions. Can simultaneously build plans/infrastructure/operating efficiency/capability while delivering significant results on challenging goals and objectives.
- Customer Partnership: Customer Partnership is about demonstrating an understanding of customers (*both internal & external) and acting consistently to add value to those customers in partnership with them (i.e. not adding value just based on their own terms/own agenda).
- Business Acumen: Business Acumen is the ability to combine analytic skill with judgment to create business plans with competitive advantage to inform current and future decision-making. This is about understanding the business, connecting the dots, being proactive and providing strategic value.
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