Technical Operations Manager, Biologics / Pharmaceutical Manufacturing
GA
Great Opportunity with Global Pharmaceutical Leader!
Technical Operations Manger - Sterile Pharmaceuticals
Global leader in sterile pharmaceuticals seeks a Technical Operations Manager to manage technical resources for the company's biologics manufacturing processes. This will include supporting technical investigations in upstream cell culture processing as well as purification process downstream. The Technical Operations Manager will also:
Global leader in sterile pharmaceuticals seeks a Technical Operations Manager to manage technical resources for the company's biologics manufacturing processes. This will include supporting technical investigations in upstream cell culture processing as well as purification process downstream. The Technical Operations Manager will also:
- Develop and implement process improvements
- Develop new process formulas and technologies to improve product quality
- Problem solve systems and process equipment
- Support process scale-up, process optimization, tech transfer as well as validation
- Work in a cross functionally with other departments to manage technical resources, ensuring equipment and processes fulfill requirements for new product tech transfer
- Lead new project analysis through feasibility studies, scoping, design, project scheduling, cost estimation, risk analysis and implementation plans
- Bachelor's degree in chemical engineering; advanced degree preferred
- 8+ years experience in a cGMP manufacturing environment
- 5+ years experience in biological development and manufacturing
- Experience with pharmaceutical process or R&D
- Strong analytical and technical skills with a progressive career history in bulk sterile pharmaceuticals or aseptic pharmaceutical manufacturing
- R&D experience
- Demonstrated ability in tech transfer, scale-up; experience with new cGMP facility design
- Experience in cell culture processes, production scale chromatography, lyophilization
- Strong project management experience
- Experience with process optimization. re-engineering, and change management
- Experience with formulation and fill-finish
- Experience working in cross functional teams in a leadership role
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