Primary Objective of Position
The Director, Global Supply Chain & Logistics shall be responsible for the leadership and management of global supply chain activities in support of Puma Biotechnology, Inc. clinical development programs and registration of Puma drug candidates. This position will oversee contract manufacturing operations related to packaging, labeling and distribution operations, and inventory and distribution drug supporting all of Puma Biotechnology, Inc. (Puma) drug candidates through the oversight and management of multiple Contract Manufacturing Organizations (CMO's), and related distribution providers.
This individual will be responsible for developing business processes supporting global supply chain activities for both a clinical aspect and for a commercial organization while maintaining compliance to all applicable requirements and meeting Puma overall objectives.
- Lead Supply Chain group in developing and executing supply to patient strategies including:
- Planning and forecasting,
- Packaging and labeling operations
- Order fulfillment
- Management of global distribution networks and development of logistic strategies
- Collaborate to develop Strategic Global plans with Regulatory Affairs, Quality and Clinical Operations counterparts to ensure supply strategies align with company’s expectations and applicable regulations.
- Manage the storage, distribution and inventory tracking of inventory through the supply chain in accordance to relevant regulations. Develop tracking systems documenting lot usage per clinical trial to ensure proper accountability and genealogy.
- Meet financial objectives of Puma by developing and maintaining accurate budget projections.
- Manage vendor selection related to packaging, labeling and distribution, comparator sourcing and any others as required. Work with stakeholders as required in selection/qualification of CMO’s and to negotiate effective supply and technical agreements.
- Build and maintain effective business relationships with Puma’s Supply Chain vendor portfolio, ensuring Puma’s objectives are being met based on quality, cost and performance.
- Leads development of Standard Operating Procedures (SOP’s) as required. Ensure department compliance with Puma’s internal procedures and all relevant requirements.
- Build, lead and manage an effective supply chain organization. Develop staff by coaching and mentoring.
- Stay abreast of current US and international regulatory guidance on packaging and labeling requirements.
- Other Duties as assigned
Skills & Abilities
- Project Management skills in multidisciplinary environment
- Problem solving ability–develops and executes complex strategies spanning global regions, analyze and resolve complex logistical issues in compliance with regulatory and quality requirements.
- Excellent Organization skills, ability to quickly adapt and react to changing environment.
- Lead multidisciplinary teams with excellent oral and written communication skills.
- Motivated and self-directed
- Strong knowledge of cGMP’s, ICH and CGXP’s
- Strong vendor management skills, including contract negotiation and legal review terms.
- Excellent business partner with ability to support, develop and maintain effective internal and external relationships.
- Financially savvy, with experience in preparing budgets and on inventory financial management.
- People development skills
- Strong influencing skills.
The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.
The physical demands of the office are normally association with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Work is performed in an office environment.
Travel may be required (up to 10%).
Education & Professional Experience
Minimum Bachelor Degree in scientific, business or health related field. Master’s degree preferable.
- Minimum of 12 years in Biotechnology/Pharmaceutical GMP environment with > 5 years of management/supervisory experience. (Manufacturing and/or Supply Chain experience).