Manufacturing Operations Specialist

Role Summary

365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives. The Manufacturing Operations Specialist is responsible for the dispensary / ISO8 area tasks including kitting and material flow, inventory management and other duties required to support the core functions. Location: Morris Plains, NJ. Shift: Sunday - Thursday 10 PM - 6:30 AM.

Responsibilities

• Adhere to all area governing SOPs, WPs, and batch records with a focus on Right First-Time performance. Ensure accurate SAP/MES inventories are maintained for all components.
• Ensure Manufacturing Support areas are maintained in an “audit ready” state.
• Ensure equipment cleaning and maintenance is performed per governing SOP requirements.
• Escalate any observed compliance or safety issues and support reconciliation of event.
• Proficient in various operating systems, including but not limited to LIMS, SAP, MES etc.
• Support monthly and annual cycle count and support all site/team projects and initiatives.
• Coordination of receiving, storage and processing of materials.
• Ensure inventory accuracy of GMP and non-GMP LN2 storage locations.

Dispensary / ISO8 Activities

• Ensure accurate SAP/MES inventories are maintained for all components.
• Ensure proper status segregation and storage of all conditioned and ambient materials.
• Ensure Kanban system is accurate, and materials are consumed per FEFO/FIFO.
• Ensure kitting/staging of initial kits are complete for each shift and timely response to kitting requests for production.
• Monitor staged kits for expired materials and to ensure utilization prior to expiry.
• Ensure all gowning materials in the ISO8 staging area are maintained to adequate levels.
• Ensure dispensary area has ample supply of non-BOM items.

Qualifications

• Required: 1-3 years of related experience in a cGMP/FDA regulated industry. High School degree required. Bachelor's degree preferred.
• Required: Strong interpersonal, written and communication skills along with problem solving and follow-up skills.
• Required: Must be well organized, flexible and work with minimal supervision.
• Required: Ability to lift up to 50 lbs., assisted.
• Required: Requires handling of chemicals such as corrosives, solvents & bio-hazardous material.

Education

• High School degree required. Bachelor's degree preferred.