Associate Director, Downstream Manufacturing

Job Description

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.Requirements:

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.

Full-time