Cell culture subject matter expert, responsible for technology transfer, scale-up, lab scale process mod-eling, process validation, and select regulatory section preparation to support the commercial launch and manufacture of new vaccines.
Degree should be in a science or engineering discipline
- Subject matter expert in cell culture process design and scale up for the site and the global tech-nology development organization.
- Responsible for managing a team of 4-5 scientists, dealing with performance evaluations and is-sues and developing personnel
- Lead cross-site & cross-functional team to establish process transfer, scale-up & validation plan, product comparability protocol and risk mitigation options. Establishes milestones and deliverables for process transfer and validation runs in collaboration with other departments at the site and other site(s); Ensure successful process transfer within schedule and cost through proactive identification of risks and mitigation steps; Drive implementation of risk mitigation steps at Novartis sites and at contract labs
- Provide manufacturing support for existing manufacturing processes at the US and European manufacturing sites using Six-sigma methodologies including troubleshooting and yield and robustness improvements.
- Plans and potentially supervises multiple projects internally, at other sites and at external manufacturers requiring initiative and judgment.
- Plans, assigns, directs and evaluates the work of technical staff when assigned to the project. May supervise lower level scientists. Performs other duties as assigned.
- Prepare project update presentations for senior management reviews; prepare sections of select milestones reports for the site
- Proactively identify potential issues and manage cross-functional resolution. Develop creative solutions to technical and organizational problems in order to keep projects on schedule. Minimum requirements Requirements:
- Ph.D. with at least 5 years’ related experience or BS/MS with 14 years' related experience
- Relevant pharmaceutical development and/or manufacturing experience
- Ability to lead team and manage effectively
- Must have work experience in process transfer, GMP manufacturing, process development and product launch in the biotechnology and/or vaccine industry.
- Process experience with viral gene vectors or vaccines is preferred.
- Must be able to effectively partner with diverse team members from various functions, multiple countries and members at various levels in organization.
- Must be a self-starter, be able to work with minimal supervision in a matrix environment and effectively manage multiple projects.
- Travel of 10% may be required (including international) to support project activities.
Novartis - 2 years ago
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...