The incumbent will be a leader in the Production organization in a supervisor role of the Cell Culture based Flu Vaccine facility in Holly Springs, NC.
- Managing a staff of shift production personnel to ensure safety and quality compliance are prioritized for manufacturing goals during scale-up/demonstration as well as commercial manufacturing.
- The incumbent will be responsible for the correct execution of production batch records and preparation of production variance reports.
- The incumbent will be responsible for technical problem solving, operational improvements, and efficiency improvements to reduce operating costs.
- The incumbent will adhere to capital and expense budgets as well as manage to standards and manpower requirements to meet production requirements.
- The incumbent will be responsible for scheduling manufacturing activities as well as coordinating equipment maintenance and validation.
- The incumbent will become a process expert and will serve as a technical resource and coach for the Production team.
- The incumbent will be responsible for developing and maintaining operator training programs and standard operating procedures.
- Development and performance management of manufacturing staff will be required.
- Utilize Novartis business systems (SAP, TrackWise, LIMS, WebTraining, Delta V, Data Historian) to release Process Orders, execute Batch Production Records and release manufacturing batches.
- Utilize IQP tools to support continuous improvement initiatives on the manufacturing floor. Minimum requirements REQUIREMENTS:
- BS Engineering or Science discipline, with 2-5 years of related industry experience preferred. Experience may be substituted for education.
- The ability to lead and influence a team to achieve desired goals is required.
- Experience in cell culture, virus production, and/or aseptic processing preferred.
- Previous experience and demonstrated results in a GMP manufacturing environment desired.
- Experience with automated systems preferred.
- Familiarity with cGMPs, regulatory guidelines, and validation principles preferred.
- Excellent organizational planning and time management skills required.
- Strong oral, written and interpersonal communication skills are required.
- The ability to work effectively in a team environment required.
- The ability to work on a shift which may include nights, weekends, and holidays.
Novartis - 17 months ago
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...