AbbVie API Coordinator I in North Chicago, Illinois
API Coordinator I
USA, Illinois, North Chicago
2 additional locations
Research & Development
Develop supply chain strategies and operational strategies to assure the pilot plant and project teams meet API and/or drug product delivery requirements. Identify any conflicts and resolve issues that may impact the schedule, including issues related to quality, safety, material or equipment availability. Resolution may require interaction with individuals who are cross-functional, global and/or senior management.
Responsible for identifying project specific requirements, such as special commodity needs, packaging and lot distribution requirements and assures all factors are ready for manufacturing start.
Collaborates with the materials manager, program manager and/or team lead to set expectations for procurement needs. Forecasts material needs to assure timely receipt, testing and release, as applicable. Identifies significant changes in forecast volumes or deliveries that may require a change in purchasing strategy or adjustment in manufacturing timelines and drives any gaps to resolution.
Collaborates with project teams and commercial operations during product tech transfer to establish expectations and set strategies for material transfers and deliveries.
Responsible for the SAP production planning for his/her assigned projects. This includes BOM maintenance, master recipes and issuing SAP process orders or equivalent to the warehouse for staging and to manufacturing for production. Issues PI sheets to production for use and maintains XSteps for production operations, as applicable. May also include generation and maintenance of material numbers in the DSP system, as applicable.
Identifies, develops, communicates and tracks project timelines, activities and logistics. Generates metrics for area KPI reviews.
Utilizes knowledge and experience to identify opportunities for improvement. Leads cross functional initiatives as a subject matter expert.
Takes a leadership role in the implementation of new systems.
Provides guidance to junior coordinators when necessary.
Level will be based on education and years of experience
Bachelor's degree required. Science based degree is preferred.
Minimum experience: 4+ years total experience in the pharmaceutical industry. Higher education (MS) with less experience will also be considered.
Must have experience in one of the following areas: Drug Development (e.g., process chemistry, formulation), Manufacturing Operations, Supply Chain, or Quality Assurance.
Proficient in the application of business requirements (e.g., standard operating procedures, quality regulations, customs, foreign trade zone, etc.)
Must have understanding of importance of compliance in a regulated environment and be capable of applying this knowledge to improve current processes.
Demonstrates strong competence of plant, manufacturing and development processes, including understanding of equipment trains, processing capabilities and commodity requirements.
Ability to work collaboratively across departments/functions and interact in a tactful, professional and effective manner.
Ability to manage and prioritize multiple tasks under tight deadlines and high pressure.
Strong problem solving and project management skills.
Strong communication skills (both written and oral).
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced