Responsible for execution of disciplined inventory and supply plans for commercial and clinical products. Plans should integrate the product and/or program directions and decisions from the perspective of commercial demand, operational governance, clinical study timelines, lifecycle management and production schedule.
The Senior Planning Analyst will develop and execute inventory and supply plans. This level will function more independently in the execution of the major duties of the position.
· Generate scenarios for demand and supply balancing, articulating assumptions, recommended alternatives and corrective actions for non-adherence to plan.
· Coordinate and maintain consistency of clinical/commercial supply strategy across product lines in compliance with Dynavax policies, procedures and regulatory authority regulations.
· Coordinate domestic and international cold chain shipments. Ensure compliance with country specific regulations to enable delivery of products to final destinations.
· Review and resolve all shipment issues (damage, temperature excursions, non-compliance). Analyze root cause and design solutions to resolve recurring problems including deviation and CAPA ownership.
· Collect, evaluate and analyze data to inform decisions and/or action plans that support program / process improvements.
· Coordinate multi-stage inventory planning through disposition (raw materials through finished goods) in coordination with Manufacturing, Clinical Operations, Commercial Operations and Quality.
· Identify backordered/low inventory and expiration risk to assist allocation decision and measure supply plan accuracy to inform safety stock requirements and inventory targets.
· Perform master production scheduling and MRP using a combination of ERP and manual systems for all products.
· Assign and prioritize release dates for manufacturing, packaging and labeling timelines, based on need and input from Manufacturing, Regulatory and Quality.
· Coordinate and execute lot use strategies with Manufacturing, Regulatory and Quality, ensuring CMC changes are approved as needed to enable lot use in the targeted countries.
· Pro-actively run situational analyses and build scenarios to address specific demand and supply constraints.
· Manage relationships with vendors as needed, including managing quotes, purchase orders and invoicing.
· Assist Finance with inventory reconciliation, forecasting and financial close.
· Support Sales & Operations Planning (S&OP) process, coordinate monthly planning meetings with Operations and functional groups to ensure that logical schedules and strategies are produced and agreed upon.
· Collect Key Performance Indicators (KPIs) to track and report supply chain performance.
· Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
· Other duties as assigned.
· A Bachelor’s degree in Supply Chain Management or related discipline.
· The Analyst will have a minimum of 5 years of planning experience in a combination of clinical and commercial supply chains in biotech/pharmaceutical industry. The Senior Analyst will have 8+ years’ experience.
· Working knowledge of cGMPs/cGDPs and pharma industry procedures and regulations.
· Theoretical and practical knowledge of sales forecasting, demand planning and manufacturing capacity management.
· Proficiency as Master Production Scheduler/Planner.
· Understand Interactive Response Technology (IRT) selection, design and management for clinical trials.
· Ability to anticipate/define problems, collect and analyze data, draw valid conclusions and execute corrective actions and preventative measures.
· Global logistics and cold chain experience is required.
· Must possess import/export expertise including customs, transportation, and regulatory guidelines.
· Strong interpersonal skills and the ability to work independently, as well as a member of a team.
· Must have exceptional verbal, written, presentation, communication and negotiation skills.
· Organizational, time management, and project management skills are required.
· Proficiency with: Microsoft Word/Excel/PowerPoint/Project and ERP software.
· Available for off-hours questions and calls with international sites.
· Must have the proven ability to make well thought out decisions under stressful and conflicting situations.
The Analyst level is a seasoned and experienced professional with a full understanding of area of specialization and the ability to resolve a wide range of issues in creative ways. This position level works on problems of diverse scope where analysis of data requires evaluation of identifiable factors and individual demonstrates good judgment in selecting methods and techniques for obtaining solutions. The incumbent at this level networks and collaborates with senior internal and external personnel in own area of expertise. Analyst functions independently on a day-to-day basis, receiving general instructions on new assignments while applying strong experience and good judgment in decision-making.
The Senior Analyst has a wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. This position level works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors and exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. The incumbent at this level networks with key contacts outside own area of expertise. Senior Analyst determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead).