Job Detail

Job Description

JOB PURPOSE:

The incumbent supervises Manufacturing Associates, schedules shift tasks, ensures cGMP compliance and safety procedures are adhered to. He/She ensures manufacturing documentation is updated and revised accordingly. System expert who can lead technical resolution and troubleshooting while representing MFG in cross functional teams.
Responsible for managing and developing direct reports.
 

MAIN ACCOUNTABILITIES:

1. Schedules and directs daily manufacturing activities, timely communicating scheduling changes/issues to their staff and management.


2. Performs manufacturing activities according to cGMP. Ensures completion of batch execution.  Evaluates test results, identifies and resolves issues.  Troubleshoots manufacturing equipment including analytical instruments and is able to make recommendations for resolution


3. Coordinates and drafts revisions to automated batch documents. 


4. Hires and develops a well-functioning team - focusing on values and culture and ensure establishment of goals and development plans for employees.


5. Trains Manufacturing Associates on process activities, including Safety and CGMP requirements.


6. Supervises validation activities, ensuring proper and timely execution of validation protocols required in the areas.


7. Coordinates manufacturing activities with other department as well as other sites; provides updates to production schedulers and works closely with quality, materials management, manufacturing science, validation, facilities, process engineering etc.      

Qualifications

• Biotech or pharmaceutical BS degree or other relevant educational background from chemical industry, food industry, pharmaceutical or biotech industry.


• Minimum 7 years solid practical experience with similar tasks, preferably with pharmaceutical processing in manufacturing or process development environment -within biotech, pharmaceutical.


• Practical knowledge with cGMP´s and understanding of biotech / pharma production processes and unit operations.


• Managerial experience is required.


• Moderate to advanced knowledge of most processing equipment.


• Solid knowledge of the engineering and scientific principles associated with their areas of responsibility


• Good communication skills with all levels


• Language skills: English fluent, German and/or French would be a strong asset