Develops final product schedules in support of clinical and commercial manufacturing and ensures finite processing schedules adhere to the business needs/goals (May include IB exp., OB expiration, Disposition/QC testing time, etc.)
Ensures schedule adherence and recommends alternatives to scheduling exceptions.
Monitors receiving, manufacturing, and shipping to meet the agreed upon schedule.
Provides communication to affected departments of schedule changes in a timely fashion.
Communicates to adjacent shifts changes and events which may affect the finite schedule.
Organizes future activities (APVs, resource closures, training, etc.) which may impact the finite schedule.
Maintains plant resource calendars to support corporate scheduling staff in creating final production schedules and to ensure processing takes place in approved/released production areas. Interfaces with corporate customer service (Dendreon Connect, Med Info, etc), Operations, and Quality to prioritize production activities and other potential schedule interruptions. Adheres to the internal business processes/guidelines with regard to planning, prioritization and communication.
Maintains proficiency in operational areas and participates in processing as needed
May provide direction to Manufacturing Operations associates as needed
Monitors, audits, and resolves manufacturing operations issues on and off the floor
Monitors and prepares manufacturing operations records
Responsible for ensuring production documentation is accurate and in compliance with all regulations and procedures
Responsible for handling departmental documentation, investigations, impact assessments, and technical guidance.
Monitors, complies, and reports production metrics
May also be responsible for other projects or tasks assigned by management.
Other duties as assigned
Uses professional concepts and company policies and procedures to solve a variety of problems.
Exercises judgment and initiative within defined procedures and practices to determine appropriate action.
Has an understanding of cGMP, GDP, and general aspects of an aseptic manufacturing environment.
Adapts well to a changing environment, is recognized as a team player internally and externally and provides strong customer service to the plant.
Uses ability as an experienced specialist to contribute to the development of concepts and techniques, and to complete tasks in creative and effective ways.
Bachelor’s degree or commensurate experience required.
Typically 2-4 years’ experience with operations management in a finite scheduling environment.
Typically 2-4 years GMP experience, biopharmaceutical experience preferred.