· Job facts
Job Summary :
The Clinical Supply Coordinator will be responsible for operations support for an assigned portfolio of clinical materials. They will interface between the clinical planning organization, Global Supply Execution Teams, material suppliers, packaging operators, and the label print room. They will be responsible for ensuring a seamless transformation of a supply forecast into an executable schedule for their assigned clinical studies. Primary responsibilities will be in the areas of label development, materials planning, production data management, and production scheduling. Depending upon experience and training interest/aptitude, the successful candidate may have a primary subject matter expertise within these fields while at the same time maintaining a minimum competency in all areas.
Job Responsibilities :
· Create and revise labeling artwork for medical products and ensure label contents meet all medical, legal and regulatory requirements.
· Monitor order status and availability, production schedules and project timelines.
· Proofread labeling artwork and incoming vendor proofs.
· Represent label development in Global Supply Execution Team (GSET) meetings and production meetings.
· Collaborate with various internal functional group members and external suppliers to provide labeling solutions in support of domestic and ex-US clinical trials.
· Communicate timelines and provide project updates to customers and business partners.
· Facilitate issue resolution by providing input and coordinating with the label print room and other key stakeholders.
· Monitor changes in labeling regulations from domestic and global agencies, including fulfilling the role of Local Label Representative (LLR) for the US as well as liaising with Local Label Representatives (LLRs) in Roche's affiliate organizations on global translations.
· Evaluate, recommend and implement improvements to the labeling process, quality, systems and policies.
· Development, maintenance and advancement of the Enterprise Resource Planning (ERP) system recipes and master data used by SSF Clinical Supplies Management.
· Lead processes to ensure successful SAP data development and maintenance.
· Collaborate closely with the Data Deployment team
· Enable and ensure appropriate integration of CLARA, R3, and APO with supporting systems.
· Lead cross-functional teams in problem identification and resolution.
· Work collaboratively and independently to solve emerging challenges inherent to rolling out new data applications.
· Support user needs for current and future applications for the Clinical Supplies Management department.
· Create SAP Recipes in collaboration with data owners to enable materials and capacity requirements planning and successful execution.
· Coordinate and lead data strategy and execution meetings with site and network representatives
· Provide technical solutions to a variety of problems of moderate scope and complexity.
· Develop solutions that are imaginative, thorough, practicable, and consistent with organization's objectives
· Adhere to change management processes to ensure data accuracy is maintained across systems
· Provide reporting and analysis required to manage key performance indicators
· Translate business requirements to technical specifications and collaborate with key stakeholders to complete requests
· Provide training on usage, enhancements and changes to business systems
· Work is performed under limited direction and guidance, with general instructions on new assignments
· Proactively recommend priorities, timelines, and resources for addressing emergent business needs
· Participate in developing courses of action that may impact multiple functions in the organization
· Network with senior internal and external personnel in own area of expertise. Represent organization on assigned projects
· Identify opportunities for improvement
· Lead cross functional and cross network teams in the identification and implementation of improvement initiatives
· Responsible for packaging Production Data Management (PDM) Data Collection.
· Responsible for Manufacturing Operations Change Request / Electronic Change Request initiation, review, and approval.
· Review MRP exception messages and take appropriate action to ensure continuity of supply – includes managing replenishment orders and rescheduling and/or canceling open orders when due dates and need dates are not aligned.
· Collaborate with external vendors and act as Replenishment Coordinator for internal network deliveries.
· Execute raw material inventory strategy.
· Establish and maintain safety stock levels.
· Partner with the Warehouse, Packaging, and QC test resources to optimize material movements / flow of goods.
· Maintain planning parameters (rounding value, safety stock, min and max lot size, reorder point, etc) and transportation lanes in SAP to ensure materials are distributed properly across the network to support production schedules.
· Monitor reports to ensure MRP is working correctly and quickly address any demand or supply gaps.
· Proactively partner with Master Scheduler, Procurement, QC, QA, and Suppliers to communicate and address supply issues and ensure materials are available on time to support operations.
· Actively participate in weekly TEMPO meetings.
· Partner with, influence, and align with the Regional and Global Materials Planning community.
· Participate on project teams in support of strategic initiatives.
Job Requirements :
· Bachelor's degree with 5+ years work experience in the pharmaceutical, biopharmaceutical or related industry, or a Master's Degree with 3+ years relevant experience, or an equivalent combination of education and experience
· Experience with ERP systems Recipe Development, Master Data and Detailed Scheduling
· Possess strong Analytical skills and understanding of systems and technical design
· Full use and application of basic Supply Chain/Business Process/cGMP theories, principles, and techniques
· Ability to effectively interpret Quality standards for implementation
· Ability to manage small projects from initiation to delivery
· Ability to independently evaluate situations and propose potential solutions
· Ability to communicate clearly and professionally both in writing and verbally
· Ability to quickly learn a broad range of skills
· Flexibility in problem solving and work hours to meet business objectives
· Experience in GMP Biopharmaceutical production facility
· Demonstrated project management skills
· APICS CPIM certification
Roche is an equal opportunity employer.
Supply Chain, Supply Chain > Supply Chain Planning
· Who we are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.