Manufacturing Operations Senior Leader

1 week ago


Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time

The Associate Director, Manufacturing Operations is a key leadership role responsible for driving efficient operations and ensuring the smooth delivery of clinical cell therapy products. This position oversees the site's operations scheduling and training capacities, with a focus on meeting customer demand and staying ahead of upcoming needs and constraints.

Responsibilities:
  • Scheduling and Training: Manage all operations scheduling, training, and compliance resources to ensure seamless production processes.
  • Capacity Planning: Look ahead 3-6 months to ensure adequate capacity and resource availability for clinical manufacture.
  • Operator Training: Create and enforce operator training schedules to ensure production schedules can be met.
  • Personnel Scheduling: Develop a process to accurately and fairly assign personnel schedules.
  • Project Management: Support and drive special long-term projects assigned by the PPU Head.
  • KPIs and Metrics: Establish and maintain operations-based KPIs to measure performance.
  • Compliance and Safety: Ensure department staff comply with corporate and site-specific HR policies, safety protocols, and business practices.
  • Training and Development: Approve job-specific curriculum for training and professional development.
  • Batch Record Review: Streamline the batch record review process.
  • Profit and Loss: Understand profit and loss for PPU's and related documentation.

In this role, you will work closely with support groups, such as Supply Chain, Training, Quality Systems, Quality Assurance, Quality Control, and others, to address short- and medium-term needs. You will also set team expectations, goals, and assist in delivering business direction for the PPU. The ideal candidate will have strong collaborative and influencing skills, ability to work well in a cross-functional environment, and flexible adaptability to company growth and evolving responsibilities.

The successful candidate must possess a Bachelor's degree in a relevant field (Biology, Biotechnology, Bioengineering, Chemical Engineering), 5-10 years of cGMP experience, 5-10 years of leadership experience, and deep understanding of cGMP and cGLP. Additionally, they should have working knowledge of financial operations, budget development, and IT skills. Strong analytical and problem-solving skills, strategic thinking, and written and verbal communication skills are essential for this role.

This is an exciting opportunity to join Lynkx Staffing LLC and contribute to the success of the Biotechnology, Pharmaceutical, and Medical Devices industries in New Jersey. If you are a motivated leader with a passion for manufacturing operations, we encourage you to apply for this challenging and rewarding role.



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