About this position
Description:
- Collaborate with the upstream manufacturing managers as it relates to the production activities andguidance of the manufacturing group.
- Responsible for manufacturing related to product development, clinical and commercial production.
- Ensuring and utilizing resources (personnel, equipment, facilities, supplies, etc.) to meet production demands.
- Direct all aspects of chemical weighing preparation for GMP and non-GMP activities.
- Direct all aspects of buffer solution preparation for GMP and non-GMP activities.
- Direct all aspects of downstream operations for GMP and non-GMP activities.
- Direct all aspects of filling and visual inspection operations for GMP and non-GMP activities.
- Ensure adequate supplies of GMP raw materials and consumables are available based on the projects.
- Responsible for process evaluation, improvement and implementation, data collection and management, creation, utilization and review of documentation, conformance to Standard Operation Procedures (SOP) and compliance to Good Manufacturing Practices (GMP).
- Lead and direct projects/programs for the manufacturing Downstream, Filling/Visual Inspection, and
- Label/Packaging groups.
- Provide training, guidance, and mentoring to junior staff and coordinate the assistance of other operations staff.
- Point person for resource planning for manufacturing.
- Subject matter expert for GMP, large scale manufacturing operations.
- Hiring, training and the development of staff.
- Assist Director of GMP Manufacturing with strategic planning and guidance of the manufacturing group.
- Experience in (any or all) technology transfer, validation, filling, and/or facility start-up.
- Thorough knowledge of bioprocess validation and associated documentation.
- Effective communication skills.
- BS degree in life or physical sciences.
- Minimum 10 years of GMP biopharmaceutical manufacturing.
- Previous management and leadership experience.
Salary Information
$170000.00 - $230000.00
Annual Salary