Associate Director, Manufacturing Operations

About the position

The Associate Director of Manufacturing Operations for Morris Plains Cell and Gene Therapy is responsible for the overall operations within the manufacturing area operating over multiple shifts 24/7/365. The Associate Director provides direction, leadership, and guidance to support roles that directly affect daily operations which are expected to produce and deliver product with high quality in a safe, compliant, efficient, and cost effective manner.

Responsibilities

• Accountable for all aspects of staffing, including recruiting talent, and strategic/succession planning.
• Ensures adequate resources and cross training to meet the demands of a multi product processing facility.
• Supports the operations site strategy and ensure tactics are aligned with strategy.
• Contribute to site financial and business goals.
• Performs prioritization of core operations, continuous improvements of projects.
• Designs and optimizes Manufacturing process to meet demands of multiple products.
• Serves as escalation point for Manufacturing issues that occur on weekdays and weekends.
• Collaborates with all support functions to ensure that the production plan is met.
• Supports process improvement initiatives and ensures that Operational Excellence is embedded in the team.
• Represents manufacturing during Health Authority inspections.

Requirements

• Bachelor's Degree in Biotechnology, Biopharmaceutical, Pharmaceutical Technology, Chemistry, Microbiology, or equivalent required. Advanced Degree preferred.
• 8+ years' experience in cGMP required, with aseptic and cell therapy manufacturing highly desirable.
• 8+ years' direct management experience.
• Demonstrated experience leading large multi levels teams (shop floor leaders).
• Project management, Lean, Operational Excellence, Product/Process Development or Regulatory experience a plus.