Director / Associate Director Cold Chain Logistics and GDP

Location:  remote, United States Category: Supply Chain

Description

SUMMARY DESCRIPTION

Associate Director/Director Cold Chain Logistics & GDP will strategically develop, manage, and lead Cold Chain distribution globally supporting a complex temperature controlled supply chain network.  Leads Global Cold Chain distribution engineering for a rapidly growing Biotech organization, including commercial and clinical distribution with CMO and 3PL partnerships worldwide.  Additionally, this role serves as the process lead for GDP compliance across supply chain network.

Collaborates cross functionally to identify, select, and implement Cold Chain solutions across all modes of transport globally.  Manages Cold Chain distribution projects including thermal packaging design, development, and implementation.  Act as Project Manager and technical expert for temperature controlled distribution across the organization.  Remain on forefront of emerging Cold Chain distribution industry best practices and Good Distribution Practices.  Establishes and governs GDP policies and oversight across all Logistics partners.

This function coordinates and makes daily decisions which effect the operations for customer deliveries globally for BioMarin.  Monitors global spending for distribution packaging.  Responsible for collaborating cross functionally with Technical Operations, Commercial Operations, Finance, Quality Assurance, and Corporate Compliance to ensure planned and predictable distribution services are provided to internal partners and external customers of BioMarin.  Ensures the safe, secure, and cost effective movement of BioMarin products worldwide.  This function is critical to the overall results of customer satisfaction, inventory integrity, and supply chain management.

The position reports to the Sr Director, Global Supply Chain Operations and works with little supervision, having the freedom to act within division and corporate guidelines in order to achieve objectives.  Due to the sensitive nature of Biological products, the incumbent must act quickly and decisively to assess urgent situations concerning customer requests, and act accordingly to provide immediate attention, correction, and execution of solution.  Must continually stay abreast of export/import and trade regulations to insure GDP compliant movement of product worldwide. 

RESPONSIBILITIES

Project Management

  • Develop and execute project plans and manage appropriately to meet changing needs and requirements
  • Manage day to day aspects of projects and ensure timely completion of deliverables.
  • Define project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders.
  • Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion. Provide valuable information related to the project status in a timely and effective manner

Cold Chain Management

  • Lead the development, approval, and execution of cold chain shipping solutions to support worldwide shipping and distribution of BioMarin products through collaboration with QA, Compliance, and Validation personnel.
  • Serve as technical expert for all aspects of cold chain packaging and shipping.
  • Assess temperature protection requirements for BioMarin products and work cross-functionally to implement solutions.  This would include managing the relationship with Cold Chain suppliers and inventory of materials at the distribution centers.
  • Provide support for shipping validation activities.  Drive Cold Chain Operational Excellence initiatives and lead implementation of enhanced processes and solutions.
  • Responsible for the investigation and resolution of in transit temperature discrepancies.
  • Conduct vulnerability analysis for goods in transit, taking into account such factors as risk, impact, and criticality.

Continuous Improvement and Operational Excellence

  • Collect, assemble, analyze freight cost data and make recommendations regarding temperature controlled distribution solutions. 
  • Develop, maintain, and improve temperature controlled transportation processes across multiple functions and / or business units.
  • Provide leadership, experience, and knowledge to diverse team consisting of middle and senior management.  Technical expertise and management in implementing projects supporting Supply Chain operations globally.
  • Provide leadership in project and change management while leading continuous improvement efforts that impact Packaging Engineering and Logistics / Transportation Operations.
  • Serves as subject matter expert for Good Distribution Practice (GDP) compliance across BioMarin globally
  • Apply expert knowledge of Good Distribution Practice in delivering logistics process oversight in the development, clinical, and commercial supply chains.
  • Perform oversight of 3PL companies and specialty distributors quality management systems; facilities, equipment, vehicles; logistics processes and documentation
  • Maintain and manage risk-based model for management of GDP activities

 

SCOPE

  • Responsible for influencing global spend in excess of $20M
  • This position will be responsible for managing the timely and cost efficient movement of goods for BioMarin globally.  The position will have responsibility for the distribution of > $2B in sales with significant growth opportunities resulting from rapidly expanding clinical trials
  • New clinical trials and commercial product launches represents a significant challenge for this position

 

EDUCATION / EXPERIENCE

  • Master’s degree in Business or related field from an accredited college or university.
  • Minimum of 10 years of experience in a cold chain logistics role in the pharmaceutical, biotech or related industry.
  • Minimum of 10 years of experience in an GMP environment
  • Project Management Certification preferred
  • Good understanding of GDP Regulations and WDA obligations
  • Significant and demonstratable experience of working in a similar compliance related role within the Pharmaceutical industry
  • Packaging Engineering degree or experience required
  • Strong interpersonal skills are required to allow the incumbent to interact with many levels in the organization
  • Ability to influence cross functionally at all levels of the organization
  • Expertise operating in a regulated environment and the transportation industry globally
  • Subject matter expert in thermal packaging within Biotech / Pharmaceutical industry
  • Track record of increasing responsibilities serving as a change agent leader
  • Establish strategic direction for Global Cold Chain distribution activities supporting both refrigerated and frozen supply chain environments
  • Travel up to 20% of time.

 

WORK ENVIRONMENT / PHYSICAL DEMANDS

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee may frequently be required to sit and talk or hear.  The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.  The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

 

EQUIPMENT

Standard office desk equipment

Commercial Operations/ Sales and Marketing, Contract Manufacturing, Supply Chain Planning, Clinical Supply Chain, QA, Validation, Finance, Corporate Compliance

 

SUPERVISOR RESPONSIBILITY

Manages the GDP Compliance and Cold Chain Engineering team.

 

CAREER DEVELOPMENT

Refer to Responsibilities section; Consistent track record of exceeding objectives and leading continuous improvement within

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated.