Associate Director Manufacturing Operations

5 days ago

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

Lynkx Staffing LLC is seeking a highly skilled and experienced Associate Director, Manufacturing Operations to join our team. As a key member of our operations team, you will be responsible for ensuring the efficient utilization of operations resources to meet customer demand.

Key Responsibilities:
  • Develop and implement strategies to optimize operations scheduling and training capacities to meet customer demand.
  • Manage all operations scheduling, training, and compliance resources to ensure compliance with regulatory requirements.
  • Assess the needs of the company to contribute to the big picture by ensuring daily operations run smoothly and as efficiently as possible.
  • Drive individual and team development to ensure a prepared and empowered workforce.
  • Meet client process demands through planning, scheduling, manufacture, and delivery of clinical cell therapy products according to established procedures, regulations, and contracts.
  • Look out 3-6 months to ensure capacity and availability of resources (room/equipment/staff) to perform clinical manufacture for processing needs.
  • Manage all training and compliance activities in the operations organization.
  • Responsible for creating, enforcing, and measuring operator training schedules in order to ensure that all production schedules can be carried out.
  • Creates and maintains a process to ensure that personnel schedules are being accurately and fairly assigned to all associates.
  • Supporting and driving special long-term projects and identified and assigned by the PPU Head.
  • Responsible for creating, maintaining, and communicating all operations-based KPIs.
  • Ensuring department staff compliance with corporate and site-specific HR policies, safety, and business policies and practices.
  • Approving job-specific curriculum for the training and professional development of department staff.
  • Responsible for streamlining the batch record review process.
  • Responsible to understand the profit and loss for the PPU's as well as all related documentation, and how these items impact operations.
  • Driving continuous improvement.
  • Liaison with support groups for short- and medium-term needs – Supply Chain, Training, Quality Systems, Quality Assurance, Quality Control, and others.
  • Set team expectations and goals and assists in delivering the business direction for the PPU.
  • Aligning departmental goals, processes, and resource allocation with the organizational strategy.
  • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Requirements:
  • Bachelor's degree (i.e. Biology, Biotechnology, Bioengineering, Chemical Engineering).
  • 5-10 years of cGMP environment, aseptic processing, mammalian cell culture, monoclonal antibody, cell processing, cryopreservation, or similar experience.
  • 5-10 years of leadership experience or equivalent combination of experience.
  • Deep understanding of cGMP and cGLP.
  • Working knowledge of financial operations and budget development.
  • Relevant IT skills (able to work with Microsoft Office and corporate scheduling system).

Environment requires gowning, hair net, safety glasses, gloves, and foot coverings. Must be capable of moving, sitting, stretching, stooping, using hands and fingers, reaching with hands and arms, talking and exchanging information, and vision sufficient to read materials.

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