- Hires and manages performance and development of staff (with up to 2-3 reports). Establishes staff priorities, promotions, and disciplinary action.
- Generates strategic plans that define program, product, and material needs and goals; negotiates internally and externally.
- Establishes and manages, in coordination with global supply chain, product supply capacities (from milk to final packaged drug product) and the external relationships to meet customers’ needs in the U.S., aligned with global supply chain directives and requirements. Focuses on Sevenfact supply to LFB’s US commercial partner (USWM/HEMA Biologics) for the US market and coordination of LFB’s SevenFact/Cevenfacta US supply activities with LFB Group Supply Chain colleagues and program needs. Supports LFB planning and management for supply of other products, as requested (e.g. IG and Fibrinogen).
- Develops and maintains relationships between several internal and external parties necessary to achieve required product supply. Communicates supply forecasts primarily to U.S. commercial affiliate and to internal operations functions (e.g. Charlton source material generation, Quality Assurance, and Logistics.
- Serves as primary lead interface for LFB with U.S. WorldMeds (USWM) and HEMA Biologics on overall commercial drug/product and supply chain (SC) actions and deliverables.
- Participates in supply chain subcommittee meetings, and other relevant meetings as necessary or appropriate, and acts on and communicates all deliverables relative to product related SC matters.
- Interacts directly with LFB Global Supply Chain management for commercial product programs and overall deliverables.
- Maintains proactive approach to understanding SC responsible activities and deliverables and addresses any problems or rate limiting steps/actions. Works creatively and timely internally and through accessing and using potential expertise within commercial partners’ SC function and knowledge/expertise.
- Ensures communication of manufacture, release, and delivery of commercial injectable medicine product to external 3rd party commercial sales partner.
- Advises on commercial product packaging activities/actions.
- Locally responsible for the electronic system required to comply with Drug Supply Chain Security Act (DSCSA), including responsibility for maintaining current and new capabilities, and compliance with quality requirements.
- Establishes full SC multi-year commercial product projections and aligns applicable SC budget projections across LFB, specifically ensuring U.S. budget performance for and SC tracking/accountability.
- Oversees SC internal and external reporting as appropriate.
- Aligns and communicates life cycle management and post-approval deliverables with U.S. market, including internal management and U.S. commercial partner.
- Engages external 3rd parties, as needed, with specific SC expertise when solutions must be found to internal issues or where timelines or scope of an issue dictates this need.
Logistics
- Develops and manages procedures and practices for material and supply procurement, receipt, storage, and inventory management.
- Develops and maintains policies, procedures, and practices to maintain current good manufacturing practices (cGMP), Occupational Safety and Health Administration (OSHA), and other regulatory compliance while delivering on business objectives.
- Oversees materials management and product inventory management in U.S. including receiving, storage, and shipping. Maintains inventory management system.
- Manages annual budget and forecast updates and cost tracking/allocations pertaining to monthly budget.
- Prepares required documentation for regulatory submissions.
- Designs and implements training program to maintain compliance with all relevant standard operating procedures (SOPs), policies, and guidelines.
- Serves as logistics representative on assigned project teams, for example coordinating transport of products or materials, assessing implementations of process or procedure changes or review function equipment performance, maintenance or improvements.
- Leads or supports the performance of shipping validation protocols, as required.
- Negotiates shipping arrangements and oversees completion of required domestic and international shipping documentation.
Materials Control
- Manages materials control. Implements and executes materials control program ensuring materials consumed (e.g. Source Material Collection) meet quality requirements and are available as needed and on time for use.
- Owns materials system ensuring raw material control process and procedures are in compliance with applicable heath authorities’ requirements, including the Food and Drug Administration (FDA) and European Medicines Agency (EMA).
- Updates and reviews procedures working cross-functionally with involved areas while coordinating delivery of consumable materials for IP1 manufacturing.
Compliance
- Chairs or co-chairs Raw Materials Review Board.
- Executes vendor, distributor, and material qualification processes.
- Ensures timely review of raw material exceptions.
- Owns raw material tracking and reporting for quality compliance.
Supply
- Generates and delivers raw materials purchase plans to Purchasing.
- Coordinates raw materials on hand and releases coordinating with internal stakeholders (e.g. Logistics, Quality, and Purchasing) to ensure on-time supply.
Program Management
- Manages assigned projects, including, but not limited to, new contractor transfers and new system implementations.
Capacity Planning
- Compiles long range requirements from key customers including LFB and 3rd party partners (e.g., USWM/HEMA).
- Generates long range supply requirements and manufacturing schedule.
- Evaluates and projects available capacities, including storage and equipment.
- Bachelor’s degree in business or related technical field. Advanced degree preferred.
- 8-12 years of relevant experience including pharmaceutical operations, business, and purchasing.
- Demonstrated prior pharmaceutical operations experience.
- Demonstrated prior experience and achievements across multiple functions within organizations.
- Prior experience purchasing and contracting significant financial agreements for biopharmaceutical activities and deliverables.
- Demonstrated business planning skills.
- Demonstrated negotiation skills with internal staff, management, and external contractors achieving desired deliverables and economics.
- Excellent forecasting and projecting manufacturing operations skills to generate short-, medium- and long-term schedules.
- Excellent oral and written communication skills with internal staff, management, and external customers, suppliers, and others.
- Ability and willingness to travel as some travel is required.
- Ability to routinely lift up to 10 pound and occasionally lift up to 25 pounds.
The salary range or this role is $190,000 to $210,000. Compensation will depend on factors such as relevant skills, experience, and internal equity.
In accordance with the Massachusetts Pay Transparency Act, we are committed to equitable compensation practices and transparency in our hiring process.
Candidates must be authorized to work in the United States without current or future sponsorship. Relocation assistance is not available for this position.