- The incumbent supports manufacturing planning, scheduling and changeover activities for the RTP Manufacturing Site supporting both clinical and commercial programs, Drug Substance and Drug Product.
- Responsible for creating and maintaining accurate, detailed daily production schedules and the medium term production plans used by Manufacturing, Materials, Quality, Engineering, Validation and Plant Management.
- The incumbent also develops and maintains facility readiness, changeover and maintenance project schedules.
- Confirms resource requirements, proactively identifies and communicates constraints with suggested alternative solutions.
- Drives issues resolution for project success and reports project status to team and manager.
- Develops the site manufacturing schedule for day to day operations and supports planning activities for medium term timelines.
- Responsible for tactical day-to-day scheduling and product changeover that meets the production demand plan.
- Interacts with manufacturing personnel to determine current completion state of production operation activities and to clarify any schedule updates/changes. Supports facility project schedules for shutdown work, technical transfers, equipment modifications, commissioning, validation, change-over, associated documentation, training, and routine/non-routine facilities maintenance activities.
- Plans, schedules and coordinates all changeover related activities. Builds electronic documentation and monitors execution in Kneat.
- Responsible for managing associated document approvals and requirements such as sampling.
- Updates Production Scheduling models for both clinical and commercial programs.
- Revises production constraints models based on process or equipment changes.
- Works closely with Manufacturing to identify facility bottlenecks.
- Collaborates with cross functional teams on facility optimization projects in order to increase facility capacity and throughput.
- Independent worker with minimal supervision; customer focused and team player
- Clearly and actively communicates planning, scheduling and changeover information or process issues with affected parties in a timely manner.
- Ability to recognize opportunities for improvement in systems or processes and recommend solutions
- Ability to identify obstacles and escalate appropriately
- Working knowledge with planning and scheduling in a GMP manufacturing facility
- Understanding of protein biologics manufacturing process knowledge and related activities
- Recognizes and performs regular responsibilities, while pursuing learning of new skills and/or processes
- Ability to influence without authority, pro-actively builds healthy working relationships between their department and other groups
- Familiarity with enterprise applications (e.g. Infor, Oracle) a plus
- Experience with statistics/analytics software packages (Excel, SAS, Minitab, JMP) a plus
- Minimum 5 years of relevant experience in a GMP regulated industry or an equivalent combination of education and experience.
Minimum Associate’s degree (AA) in Chemical/Biochemical Engineering, Supply Chain Management, or other related business/science/technical field;
Bachelor’s degree (BS) preferred
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.
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