Purpose:

The Supervisor of the API Project Coordination team is responsible for project planning, production planning and materials management in the API Pilot Plant. This includes providing project coordination support for biologic and small molecule development programs across therapeutic areas. They work with key stakeholders to set project timelines and ensure clinical supplies are delivered on time, evaluate processes for potential issues and generates/leads proposals to implementation. The individual has a technical, supply chain and/or operational background allowing the them to identify the challenges related to the development of new products. The individual will maintain project documentation including presentations, meeting minutes, action items, schedules, contracts, etc. for assigned projects as well as manage the electronic systems utilized for planning and materials management. The individual must be flexible in the ability to work during early mornings or late evenings to meet global business needs.
 
Primary Responsibilities:
•    Responsible in overseeing the pilot plant coordinators supporting the production plan in providing guidance, coaching, and proper strategic direction.
•    Provide project coordination/management, supply chain & logistical support for multiple global project teams (agenda, minutes, action item follow up). Schedules and leads cross functional team meetings with both internal and external partners.  Identifies and resolves bottlenecks and team dynamic concerns.
•    Ability to lead clinical manufacturing projects with extremely complex biologic and small molecule supply chains emphasizing external interaction especially with cross-cultural teams across multiple global sites (Ludwigshafen, Puerto Rico, Sligo, ABC and TPMs) in the context of managing logistics for an internal/external project and/or functional area initiative. Internal logistical support of internal project leader and core team.
•    Ensure effective, accurate and timely communication of critical information to internal and external project team members.
•    Ability to interact with higher level personnel (Director Level and above) across development teams including personnel from development, purchasing, quality, analytical and regulatory.
•    Collaborates with development and process engineering when bringing new products into the pilot plant. Has an understanding of both product development and manufacturing and can identify transitional challenges between the two.  Leads all materials management tech transfer elements for projects to commercial and/or TPM sites.
•    Leads scheduling and supply chain activities with multiple global partners and sites. Leads the resolution of schedule conflicts. Manages manufacturing prep activities including materials management to enable manufacturing to start on time.  
•    Business owner of the supply chain management platform (SAP) for the pilot plant. Leads the implementation of new SAP systems or improvements introduced in the plant.  Manages the SAP manufacturing and production planning process including SiBR, Purchase Order management, Process Order management, BOM maintenance and Material Master maintenance.
 
 

Basic:
•    B.S. in Chemistry, Biology or related scientific area or equivalent and relative work experience.
•    Minimum of 8 years of experience in Operations, R&D, supply chain management, and/or related area.
•    Experience in a cGMP environment is highly desired.
 
Key Stakeholders:
Project team leads including the API lead team, Program Managers, CMC teams, QA and Regulatory
Coordination/Supply Chain teams from other AbbVie sites
Purchasing
Global Trade Compliance