|Date Posted||August 12, 2020|
|Address||525 Verona Rd|
How will you make an impact?
As a member of the operations team responsible for cell-based manufacturing and services, you will be responsible for the manufacturing of cell lines and cell-based products.
What will you do?
- Management of cell-based product manufacturing including cell culture, QC process and data analysis, and planning for schedule and materials.
- Maintain multiple cell lines in a variety of cell backgrounds utilizing aseptic technique.
- Demonstrate thought leadership. Identify opportunities for improvement and minimize errors by applying technical skills and critical thinking.
- Management of schedule and key metrics for product manufacturing and custom project deliverables.
- Complete work orders according to protocol and analyze data using data analysis templates and manufacturing batch records.
- Support new product integration by participating in planning and validation of new products and equipment.
- Participate in root cause analysis and drive continuous improvement.
- Monitor inventory levels of raw materials to support production schedule.
- Perform lab support functions including reagent preparation and routine equipment maintenance.
- Maintain complete and thorough documentation including manufacturing batch records, writing SOPs, and updating existing documents as processes change.
- Respond quickly to changing priorities and can handle multiple projects with potentially overlapping deadlines in order to meet customer expectations.
How will you get here?
- Requires a Bachelor's or Advanced degree in Biology, Chemistry, Biochemistry, or other related discipline
- Experience in the methods and techniques of mammalian cell culture
- Experience working with adherent and suspension cell lines in an antibiotic free environment.
- Experience with manufacturing in bioreactors and use of Tangential Flow Filtration.
- Experience with an ISO9001:2015 Quality Management System to follow detailed protocols and manage deviations and to work across functions to monitor inventory and supply chain of raw materials
- Demonstrated ability to identify and solve problems
- Excellent verbal and written communication skills and the ability to interpret and summarize scientific results
- Demonstrate thought leadership.
- Ability to identify opportunities for improvement and minimize errors by applying technical skills and critical thinking.