CMO Logistics Specialist
Who We Are
At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.
The Position
Purpose:
* The CMO Logistics Specialist acts as a liaison between Manufacturing Collaborations (MC), the CMOs and Genentech’s plants and logistics functions and is responsible for the detailed scheduling of orders and material movements to and from contract manufacturing sites.
* The Logistics Specialist ensures that all materials are available and delivered to the CMO on time in order to support scheduled production and releases orders to allow the CMO (through the MC Site Managers) to execute and to close orders upon completion.
* The Logistics Specialist monitors the detailed production and shipping schedule in order to identify and resolve any variances that are occurring and coordinate required changes with the CMO. He/she also follows up to identify root causes for such variances and the corrective actions required to prevent their reoccurrence.
* The Logistics Specialist provide support to the CMO with all issues related to logistics and inventory management and provide guidance for material handling and any other questions that arise.
* The Logistics Specialist is responsible to the accuracy of inventory records and status in Genentech’s ERP system for all GNE-owned material that is at the CMO site and works with the CMO to update these records as material movements/consumptions occur.
Responsibilities:
Ensuring material availability for CMO production:
* Perform material requirements planning for multiple sites
* Monitors the detailed production schedule at assigned CMOs to identify material requirements and other preparations required to ensure readiness for production execution
* Coordinates with supplying plants to ensure alignment and understanding of CMO material requirements and shipping dates
* Ensures material availability and/or that production/delivery plans at supplying plants/warehouses are aligned with material requirement and shipping dates
* Coordinates with Quality to ensure that material release/disposition plans are aligned with required shipping dates and monitor progress of release/disposition process relative to schedule and shipping requirements
Transportation scheduling and coordination:
* Creates, converts and maintains Stock Transfer Requests (STRs) and Orders (STOs) and/or Purchase Orders for required materials
* Coordinates and/or schedule shipments with carriers and/or GNE Transportation.
* Works with GNE Transportation Import/Export functions to ensure that international shipments are properly coordinated with freight forwarders or customs agents and that materials clear customs without issues
* Coordinates with warehouse and other logistics functions to ensure that materials are prepared and shipped on time
Logistics schedule management:
* Identifies any delays during the manufacturing/release process that may have an impact on the scheduled shipping dates and works with relevant functions to avoid delays to scheduled delivery dates to CMOs
* Identifies, analyzes and escalates (to Master Scheduler or manager) schedule conflicts or delays that impact delivery dates to CMO
* Coordinates any required changes with CMO
* Monitors the shipping/transportation of materials to/from CMO sites to ensure successful and on-time delivery.
Materials management:
* Manages and releases process orders to ensure a minimum of 7 days of orders have been released.
* Performs goods receipts of materials into CMO inventory locations upon delivery and monitors CMO inventory and material movements to ensure accuracy
* Performs regular inventor counts with each CMO and ensure updates GNE inventory records if necessary
* Allocates materials to production orders (in coordination with product planners as necessary)
* Provides guidance to CMOs and addresses questions and issues related to material handling, inventory and transportation
Performance management and projects:
* Monitors Key Performance Indicators (KPI’s) and supports root-cause analysis
* Executes all logistics process and other responsibilities in accordance with established business processes
* Identifies areas where existing business processes are not sufficiently defined/documented and/or require improvement
* Works with management to initiate improvement projects to address process deficiencies or improvement opportunities
* Collaborates with various groups and OE resources while working on cross-functional teams to support improvement projects and root cause analyses
* Takes responsibility for action items and tasks arising through such cross-functional teams and root-cause-analysis exercises and executes them to accomplish the team’s objectives
Who You Are
Requirements:
* Bachelor’s degree in biological, engineering, business, physical sciences and/or related area.
* Minimum 5 - 7 years experience in a GMP BioPharmaceutical production environment (production, warehouse or supply chain)
* Strong written & verbal communication skills
* Minimum 4 years experience using ERP systems such as SAP.
* Ability to effectively collaborate with all levels and across the organization as well as with external groups (e.g., carriers, CMOs).
* Ability to operate effectively to support cross-functional teams in order to ensure business objectives are achieved.
* Ability to operate under limited supervision, taking initiative within scope of responsibility and communicating effectively with manager
* Good problem solving skills and ability to seek solutions which are not readily apparent in order to ensure reliable execution
* Excellent interpersonal and team-working skills
* Strong customer-service orientation
* Attention to detail
* Punctuality and accuracy in execution of transactions, data maintenance and other job responsibilities
* Ability to analyze and monitor data in information systems (e.g., SAP) to identify schedule/material discrepancies, inventory errors and other issues
* Proficient in MS Excel and other MS Office applications
* Knowledge of material handling, warehousing and shipping principles
* General understanding of inventory management principles (safety stock, JIT, FIFO/FEFO, etc)
* Knowledge of pharmaceutical manufacturing processes (large and small molecules) in the areas of API manufacturing, filling and packaging
* Experience with cold-chain transportation and shipping validation principles
* Experience in writing/editing of SOPs and business process documentation
Preferences:
* Experience with contract manufacturing operations and material transportation
* APICS CPIM certification.
* Knowledge and application of project management methodologies (e.g. risk analysis and mitigation).
* Knowledge and application of problem resolution methodologies and root-cause analysis tools
* Experience in process mapping
* Basic knowledge of cGMPs, FDA, regulatory guidelines and validation principles, in particular as they relate to logistics and inventory.
The next step is yours. To apply today, click on the "Apply online" button below.
Genentech is an Equal Opportunity Employer.
