Clinical Supplies Packaging Manager (CSPM) - Altran - Malvern, AR

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Altran Innovative Product Development is a small company within a big company. About 150 US-based engineers working primarily in our Burlington, Massachusetts office, are deployed in small teams to accelerate the development of complex cloud-based software solutions and electro-mechanical products.

Altran provides a full complement of technology consulting, software and product development services to clients ranging from established startups to Fortune 500 companies. Currently, we are engaged in the development of next-generation semiconductor manufacturing systems, diabetes management solutions, automated warehouse robotic systems, clinical diagnostic systems, commercial-grade hot beverage dispensers, and clinical data management solutions, to name a few.

Dozens of teams of highly skilled Altran engineers participate in several new product introductions each year. At Altran you will face a steady stream of new client challenges and work with a variety of talented coworkers, as you keep pace with the technological trends driving each generation of new products. Each engineer has the opportunity to make highly visible and valuable contributions. Every project represents an opportunity to learn and grow as an engineer, and as a leader.

Altran is looking to hire a Clinical Supplies Packaging Manager (CSPM) in the Malvern, PA area. You will be providing project management support to a multinational pharmaceutical company that also manufactures vaccines for global distribution. The client has offices in over 50 countries with operations in several states across the United States. This position is based in Great Valley PA.

This position is based in Great Valley PA however travel to Swiftwater PA may be required during the first 2-3 weeks in order to complete the position on-boarding and training.

General Responsibilities

• Organize and coordinate the operational packaging and distribution activities and ensure alignment with the project strategy level.
• Provide:
  • The packaging design
  • Packaging instructions and associated documentation
  • Investigation medicinal product (IMP).
• Ensure the IMP availability within the timelines, in compliance with GMPs and related regulations, protocol, productivity and costs.

Key individual accountabilities

• Ensure Investigational Product availability in compliance with GMPs and related regulations, protocol, productivity and costs within the timelines.
• Responsible for packaging design strategy.
• Study set up technical expert.
• Ensure packaging and distribution operation including constraint consideration.
• Delegate/Coordinate/Validate the operational activities to CSPM support.
• Perform its missions in accordance with the GMP and SOPs

Key shared accountabilities

• Packaging and distribution specifications (PADIS)/Label specification form (LSF) co-validation with Clinical Supply Chain Team Manager (CSC TM).
• Implement the clinical studies production plan defined by the CSC TM.
• Align the local and global equipments capabilities with the demand.
• Ensure packaging items supply strategy.
• Ensure a reliable scheduling (ORTEMS window).
• Contribute to CSC process improvement.
• Risk management of IMP supply, Quality and Change Control.

• Bachelor’s degree in Pharmacy, Health Science, Biology/Chemistry, Engineering or Business
• Administration.
• Minimum of 5 years in the pharmaceutical industry or equivalent experience.
• Minimum of 4 years’ experience in a clinical supply chain environment working closely with a production group in a team environment.
• Demonstrated project management skills, leading teams and decision making skills required.
• Must possess experience managing multiple, complex clinical supplies projects simultaneously.
• Must possess strong problem solving skills using creative and innovative thought.
• Must be customer focused.
• Must have attention to detail.
• Excellent organizational, leadership, written and oral communication skills.
• Demonstrated excellence in working with inventory systems (i.e. Rockwell automation, SAP), MS Word, Excel and flow diagramming software required.
• Fluent in English (written and spoken).
• Excellent interpersonal and communication skills.

Desirable but non-essential skills:

• Experience with planning software such as MS Project, material flow management tools and Materials Requirements Planning (MRP).
• Expert knowledge of package design and materials; label generation software; batch record design.
• Ability to read, write and understand French.

Equal Opportunity/Affirmative Action Employer; M/F/D/V

* This article was originally published here