- Everything at our company begins with the unmet medical needs of people.
- Our company is a research-based pharmaceutical company.
- Our company has biotechnology and manufacturing facilities located in Carolina.
- The candidate will be responsible for providing technical support to the large scale Insulin API purification process.
- Responsibilities also include data analysis, process troubleshooting, technical investigations, process change management, and supporting technical transfer activities.
- Optimize the production processes to increase yield/quality, reduce variability and reduce manufacturing costs of both new and existing processes.
- Continuously monitors the manufacturing processes to ensure that it remains in control and capable and in a validated state.
- Trouble shoots any issues that arise, using strong data-driven decision-making processes.
- Own change controls, deviations, annual product reviews, quarterly product process assessments and validation exercises associated with the process.
- Partner with Production and Quality Control areas to manufacture products in compliance with Global Quality Standards.
Education and Experience
- BS or MS in Chemistry, Biochemistry, Microbiology or Engineering.
- Ph.D. graduate degree on Biochemistry is preferred.
- Preferred Minimum of one (1) year of experience in industrial scale protein purification operations.
- Demonstrated strong scientific and technical knowledge in protein chemistry and purification, analytical principles, statistical data analysis, process validation, GMP and FDA regulations.
- Computer literate, Team work oriented, Strong written and verbal communication skills - English and Spanish, Excellent presentation skills, demonstrated troubleshooting and problem solving skills, willing to travel as required.
- Flexibility to provide technical support and continuity on 24 hours process operation.
- Ability to work across multiple levels of the organization is essential.