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

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Job details

Job Type

Full-time

Full Job Description

Capgemini Engineering combines, under one brand, a unique set of strengths from across the Capgemini Group: the world leading engineering and R&D services of Altran – acquired by Capgemini in 2020 - and Capgemini's digital manufacturing expertise. With broad industry knowledge and cutting-edge technologies in digital and software, Capgemini Engineering supports the convergence of the physical and digital worlds. Combined with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 52,000 engineer and scientist team members in over 30 countries across sectors including aeronautics, automotive, railways, communications, energy, life sciences, semiconductors, software & internet, space & defence, and consumer products.

Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of 270,000 team members in nearly 50 countries. With its strong 50-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2020 global revenues of €16 billion.

Get the Future You Want | www.capgemini.com

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