Position Summary:

The Director, Kit Production is responsible for Operational Planning, Strategy, Quality and Delivery of Clinical Trial Kits for distribution within the US and Abroad. Partner closely with Inventory Management and Global Shipping & Logistics Teams to ensure Client and Business Needs are achieved for U.S Labs.

Essential functions of the job include but are not limited to:

• Advise Project Managers and Proposal Writers on suggested kit components for intended use
• Work with Proposals and Finance Teams to ensure costs for Kitting activities are within / at / above margin
• Plan, Coordinate and Oversee all Kitting Activities; including Staff required to manage on-going Clinical Trials; ensuring Deliverables are met On-time and Error-Free
• Design and Redesign (as needed) Kitting Procedures and associated paperwork for an effective, streamlined process with impeccable quality
• Provide ongoing Kit Forecasting both short and long term for all Projects
• Determine future Kit Build Schedules by creating Projections with Project Management team, Scientific Team, etc.
• Ensure all supplies are ordered appropriately based upon a specified timeframe of Kit Needs
• Work with Project Managers to track Kit Usage against Schedules of Events and ensure kits nearing expiration dates are replaced
• Maximize Utilization of kit components across multiple projects
• Track expiration dates for supplies and implement mitigation for contents near or at expiry and execute corrective action where applicable
• Work with IT to fully utilize BSI and any future tools for Kitting and entire Supply Chain Management
• Identify and implement systems and tools consistent with current Best Practices for the Pharma Industry (Domestic and International)
• Provide and Support Strategic Direction for Global Kit Production
• Actively Participate and Support Process Improvement Initiatives
• Track Actionable Kit Production Performance Metrics for Production, Efficiency, Quality, etc.
• Secure required Licenses, Permits for product shipping Requirements for Studies and with Couriers, as necessary
• Serve as a Point of Escalation to provide guidance to staff and/or directly resolve issues with Partners and Stakeholders
• Participate in Internal and External Calls to support each Project as necessary

Lead or Ensure thorough Investigation and Documentation of any Non-Compliance involving Kit

Production

• Ensure Courier compliance to Business Review Meetings and other interactions that fosters Continuous Improvement between Parties
• Manage Kit Production Team for Growth and Development
• Identify areas for improved Efficiency, Effectiveness, and Cost Savings
• Ensure Kit Production area is compliant to Standard Operating Procedures, Regulated Standards, Quality, and Safety
• Carry out other Duties/Project, as assigned

Qualifications:

Minimum Required:

• Bachelor’s degree in Life Sciences or related field
• 8 years’ experience in Operations Management
• 2-3 prior Supervisory Experience

Other Required:

• Experience managing a facility that supports medical research
• Strong verbal and written communication abilities
• Effective Decision-Making skills
• A strong team leader with excellent interpersonal skills
• Demonstrated experience mentoring and developing team members
• Able to travel both domestically and internationally including overnight stays
• Must have and maintain a safe driving record and provide proof of such on an annual basis.
• Must be able to read, write, speak fluently and comprehend the English language

Preferred:

• MBA
• PMP Certification
• Clinical Trial Kit Production experience, to include Management of Production Processes and Staff
• Experience working in a Medical/Clinical Laboratory