Our Cell & Gene Therapy Biotechnology CDMO Client is seeking a Supply Chain Specialist who will be responsible for assisting in the day-to-day operations of Supply Chain. This includes kitting, cycle counting, reorder point/MRP maintenance, transporting materials, shipping, and receiving. Must maintain working knowledge of and participate in the coordination of and distribution of operations materials and inventory control activities.

• Ensure full cGMP compliance
• Develop, maintain, and optimize KPI’s relating to kitting tasks and inventory levels
• Document creation and revision for Standard Operating Procedures (SOP), Work Instructions (WI), GMP Forms and Part Number Specifications (PNS)
• Deviation investigation and CAPA creation/implementation with all relevant associated documentation
• Participate in and performs root cause analysis on all variances
• Prepare reports to Senior Management for performance KPI's
• Work directly with internal and external stakeholders on projects of existing and prospective clients to ensure appropriate capacity, improve quality, adequate sourcing of critical deliverable
• Assist in year-end inventory management activities (physical counts, cycle counts, etc.) and other materials management-related responsibilities when called upon to assist
• Collaborate with Finance regarding pricing, delivery, and receipt issues. Follow through with root cause actions items and tracks and records all actions/issues
• Creation, tracking and reporting of critical Supply Chain (KPIs) is required
• Assist in developing processes which improves productivity and streamlines activities related material procurement, management, shipping and receiving and storage
• Escalate any concerns related to material readiness or material availability; develop effective risk mitigation strategies
• Create spreadsheets to track/identify cost analysis, supplier on time, quality issues and continuous improvements
• Create and manages Change Controls for SCM-related changes
• Maintain and support client satisfaction at a level that ensures account retention
• Assist and promote communication and successful working relationships with other functional areas within the organization and outside vendors which effect the Supply Chain functions and effectiveness
• Assist in all areas of operations with day-to-day needs related to shipping and receiving and material management needed to satisfy client’s requirements.
• Review, create, and monitor departmental Protocols, Change Controls, CAPA’s, and Deviations ensuring compliance.
• Additional responsibilities and objectives will be added as needed based on business and area needs.

REQUIREMENTS

• BA/BS
• 3-4+ years of experience in Materials Management
• Experience in a cGMP manufacturing environment
• Ability to prioritize effectively and to work multiple projects and meet tight deadlines
• Comprehensive understanding and extensive practical experience with GMP quality systems and procedures
• Self-motivated and able to collaborate well cross-functionally with other department managers and personnel
• Proficient in MS Office, ERP, and document management systems
• Ability to think strategically and tactically (detail-oriented)
• Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
• Analytical and problem-solving skills
• Ability to multi-task is essential
• Project coordination
• Demonstrated ability to work creatively and effectively in a fast-paced CDMO environment
• Strong interpersonal, communication, and analytical skills, capable of producing executive-ready presentations with little guidance, meeting facilitation, training and presentations
• Quality mindset
• Ensure all processes and procedures related to SCM are in full accordance with GxP, CFR, site quality systems, company policies and promote a culture of quality, compliance, and excellence
• Set expectations for operational excellence and Right First Time (RFT) execution
• Some extended hours as required to meet deadlines and other team commitments
• Must be able to work during the weekend, holidays and as required by the company person, and on the telephone
• Must be capable of using hands and fingers to operate a computer and other office productivity

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Lynkx Staffing LLC specializes in placing talented professionals in the CAR-T, Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey.

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