The Project Management Associate of Oligo Production is responsible for the oligonucleotide manufacturing operation and implementation of key customer projects to meet production goals, quality, and cost objectives. Perform activities in concordance with FDA-QMS/QSR and ISO-9001 standards; ensure compliance with environmental, health and safety regulations. Select, develop, and evaluates personnel to ensure the efficient operation of the function. Plan and administer procedures and budget, serve as a manufacturing representative and technical expert. This position is full time onsite in Louisville KY, Monday to Friday.
RESPONSIBILITIES:
- Leads the teams and manages individual contributors (Supervisor, Team Leads, Production Chemists, Lab Technicians, contractors).
- Coordinates the activities of project(s) with responsibility for results in terms of timelines, cost, process implementation and employees.
- Manages Red Folder/ VIP customer list projects
- Works on problems of diverse scope including multiple projects and/or objectives.
- Develops and administers schedules and monitors progress (KPI) against objectives. Safety/Quality/TAT/5S
- Prepares KPI reports and communicate regularly with other managers, upper management, and other designated contacts within the organization.
- Coaches subordinate(s) on job performance and development.
- Leads validation activities of new projects and equipment.
- Leads Kaizen and other improvement projects within department.
- Ensures BOMs and manufacturing documents are current, effective and maintained properly in electronic document management system.
- Reviews weekly KPI reports
- Coordinates weekly safety training and recruitment process within department.
- Ensures and adheres to GMP compliance and maintain a clean/ traceable work environment.
- Production Schedule Alignment (Outline deadline requirements for Production, and follow up with schedule to make sure deadlines are met)
- Point of contact for QC questions regarding RF/VIP projects (reviewing MS/HPLC traces before passing to next production step)
- Provide updates/ Delays on RF projects (Tracking for RF and VIP projects)
- Perform activities in concordance with FDA-QMS/QSR and ISO-9001 standards