Oversees the execution of sales and operation production planning based on demand forecast, production plan, and customer purchase orders to ensure 100% product availability to our US, EU, Japan, and Rest of World (ROW) markets/customers. Serves as a driving force towards the identification and resolution on variations between forecast and actual sales, as well as any material availability issues that impact production and demand plans. Additionally, this position is the primary accountable person responsible for the supply of commercial Gliadel product at the appropriate times in the correct quantities and mix. Maintains appropriate inventory levels for all steps of the manufacturing process from raw materials and API through all finished goods SKUs. Provides measures and information to leadership by generating, reporting, and monitoring inventory levels on a weekly and monthly basis. Works with internal and external Client departments, partners, and vendors to generate, procure and approve printed materials to meet business needs. Works closely with Global Gliadel Regulatory Lead to ensure global compliance of printed materials and manages inventory and transitions to minimize obsolescence.
Responsible for global Gliadel demand forecasting, which is used for Business Planning and Financial Forecasting. This is created by working directly with global partners and affiliates.
Serves as the liaison between Customer Service and Gliadel Operations/Baltimore Site; and is a member of project teams for new (Gliadel) market launches and initiatives. Point contact for Finance regarding production plan, absorption, standards development, and manufacturing activities. Serves as facilitator of the Global Gliadel Strategy team – particular for launches, market partnership changes, regulatory variations, and/or repatriations.
This position will be responsible for developing a recommendation for ongoing and uninterrupted supply should any product supply issues arise; and would ensure that this is communicated and endorsed by both appropriate EDCS Unit President and Established Products Group Director.
1. Leads the development, maintenance and execution of the production schedule and production plan for Gliadel based on demand forecasts/actual orders for US, EU, Japan, and ROW/Global markets. Leads multi-functional Gliadel planning meetings at the site. Utilizes appropriate tools and measures to assess status against plan and adjust activities as required. Maintains master schedule for all activities within the Production area (manufacturing, packaging/labeling, shipping, shutdowns and outage work, training, annual qualifications, etc.). Tracks and communicates product forecast. Primary contact with partners/affiliates for monthly demand forecasts and product delivery schedules.
2. Generates, procures, and approves printed materials for US, EU, Japan, and ROW/Global markets, with input/assistance from Client departments and vendors based on approved copy and direction from Regulatory Affairs. Works closely with Regulatory, Quality, and Manufacturing to coordinate the introduction of new materials into the operation as well as the rejection/destruction of older revisions. Supports new market launches and repatriations.
Represents planning on all product related project teams to ensure there is adequate
inventory/materials to meet global customer demand.
3. Maintains appropriate and strategic inventory levels for all steps of the manufacturing process
from raw materials and API through finished goods and generates, reports, and monitors these
levels on a weekly and monthly basis.
4. Resolves variation between forecast and actual sales that impact the production plan. Serves as
primary Gliadel interface with Finance for routine production forecasting, standards
development, and related questions.
5. Primary liaison between Customer Service and Manufacturing as well as EU 3PL and
Manufacturing. Coordinates internal efforts for shipment of Gliadel finished goods for both
domestic and international commercial distribution. Communicates status of shipments and
purchase orders to Customer Service/Commercial Operations. Ensures that appropriate SAP
transactions are made in a complete and timely manner.
• B.S. in Business Administration, Life Science, Engineering or related field, concentration in
Operations a plus
• 5-10 years’ experience in Manufacturing in areas such as Material Planning, Operations, and/or
• Minimum of 5 years master scheduling experience in a fast-paced manufacturing pharmaceutical
• APICS Certification – C.P.I.M. Certified in Production and Inventory Management is desired, but not
• Hands-on experience with planning software packages such as SAP
• Detailed knowledge of Microsoft Office including Word, Excel, and Project
• Broad knowledge of forecasting, product distribution, inventory control, pharmaceutical
manufacturing processes, master scheduling and pharmaceutical purchasing. Thorough
understanding of all demand chain functions and associated primary roles and interfaces.
• Highly developed interpersonal skills, which are required in order to effectively deal with all levels of
the organization, as well as outside vendors/partners
• Solid analytical skills in forecasting and anticipating production needs and capabilities
• Strong working knowledge of, and ability to effectively lead, global Sales & Operations Planning
• Familiarity with FDA cGMP regulations
• Excellent verbal and written communication skills. May often represent Gliadel and Client to outside
• Intercultural agility to effective work across cultures on time sensitive and contract-driven tasks
where language may sometimes be a barrier
• Excellent organizational skills and strong attention to detail
• Ability to lead and/or participate in multi-functional and global teams
• Values consistent with Client Values and an intrinsic understanding of the hhc Mission and the need to always think first of the patient
Source: Job Diva – Job Listing