Current Contractor leaving April 15th, and manager wants one week of overlap.
Responsible for delivering skilled Packaging engineering work on an assigned projects.
Provide advanced technical expertise to the Global Packaging Technology organization in their respective area or areas of specialization (i.e., Packaging Technology, Package Design and Component Development, Packaging Process Development & Optimization, Packaging Qualification, etc.).
Execution lead or support for one or more processes in their respective area of specialization, including but not limited to:
o Packaging Innovation/New Technology Acquisition
o New Package Introduction
o Packaging Component/Artwork Specifications
o Packaging Component Technical Drawings
o Packaging Process Development and Optimization
o Identification and qualification of alternate sources for packaging components
Support the development and maintenance of technology capability strategy, which defines the capability we need to deliver our services and the actions we need to take to maintain and continuously improve that capability.
Lead, manage and execute all aspects of a packaging project. Accountable for delivering on specific performance indicators.
Will work with external contract packaging network to create or enhance packaging capabilities to deliver the needed capacity, quality and quantity of packaged goods required by our patients. Will partner with contractors to ensure quality in product packaging and drive elimination of customer complaints relating to packaging.
Must build and maintain strong relationships with key internal and external partner organizations including but not limited to; Component Suppliers, Contract packagers, Product Strategy Leads, Quality Assurance, Procurement, Business Development, Research and the Brand Teams.
Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, risk-management based solutions to complex technical challenges.
Lead and conduct complex technical investigations.
Authors, reviews and approves regulatory and technical documentation; including but not limited to CMC, SOPs, Validation Master Plans, Change Controls and Technical Reports.
Interface directly with all Customers and ensure the highest level of Customer satisfaction.
Education & Experience
Degree in Packaging Science, Technology or Engineering with 8 or more years relevant experience in managing technical programs such as:
o New technology acquisition
o Equipment qualification
o Process development, scale-up and optimization
o Package design development
o Technology transfer
o New Product Introduction process
o Qualification of packaging components from alternate sources
In-depth technical knowledge of primary, secondary and tertiary packaging materials including the manufacturing/printing processes used to produce the components.
Experience in global product launches and the associated CMC regulatory requirements.
Solid organization, problem solving, project-management, decision-making, judgment and team-oriented skills are essential.
Demonstrated ability to simultaneously manage multiple projects of variable complexity.
Strong technical, interpersonal, communication and leadership skills.
Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and DEA Regulations is preferred.