Project Management Specialist, External Mfg - United States
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- This role supports the management of Contract Manufacturing Organizations (CMOs) responsible for the production of clinical and commercial drug products, finished good intermediates, and finished goods.
- The candidate will support operational activities such as day to day entry of production data provided by CMOs, submission of shipping requests to transport both incoming ingredients (to CMOs) and outgoing manufactured products (from CMOs), and monthly inventory adjustments.
- The candidate will also support tactical operations such as creating and managing batch related master data, creating batch production documentation, purchase order administration, forecasting communication and follow up, materials management and change control.
Additional responsibilities include:
- Ensure timely and accurate batch management in Oracle R12 (following the required CMO lead times) beginning with batch creation and progressing through to batch release, step execution, and ultimately batch closure.
- Ensure purchase orders are created and sent to CMOs in time to reserve their capacity for the requested production slots, and approve the related invoices upon production completion.
- Enter transport requests into Oracle R12 and collaborate with Logistics to ensure timely delivery to and from the CMOs, 3PLs, and internal sites, as required.
- Initiate and manage change controls in Agile PLM to support the external manufacturing team.
- Monitor and evaluate KPI metrics to measure CMO performance.
- Support the Business Process Owner and the global alignment of standard practices.
2-4 years of experience in a pharmaceutical/biotechnology company is required; experience working with external manufacturing sites is a plus
Bachelor’s Degree in supply chain, management, some scientific discipline, or other related field.
- 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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