Director, Finished Product Packaging

DSJ Global is currently partnered with a leading biopharmaceutical company who is looking to add a Director of Finished Product Packaging to their team. This position will provide technical leadership for packaging component design and finished product technology transfers and manufacturing, including CMO oversight to ensure successful cGMP production. The incumbent will also lead the labeling/artwork business process supporting clinical and commercial labeling.

Responsibilities:

• Lead activities in the design and development of packaging components including thermoformed trays/lids, inserts (prescribing information, medication guide, instructions for use), cartons, shippers, and associated labels for primary, secondary, and tertiary packaging
• Work with internal and external partners, including CMOs and 3^rd party consultants to design, prototype, optimize, and approve packaging components and artwork
• Identify, design, execute, evaluate, and document studies characterizing packaging and labeling systems performance based on solid scientific and engineering principles
• Lead technology transfers for finished product/combination product (e.g. vial, prefilled syringe, autoinjector, or other drug delivery devices) manufacturing including unit operations of device assembly, labeling, and packaging
• Work with CMOs to ensure technology transfer activities are executed per process development procedures and best practices
• Identify, design, execute, evaluate, and document studies characterizing finished product processes based on solid scientific and engineering principles
• Oversee and support the development, review, and approval of clinical and commercial labeling components with internal stakeholders and external partners (CMOs and print suppliers) to ensure the accuracy of labeling components.
• Support the use and development of current and new tools, technologies, and processes to enable efficient label development and approvals.
• Ensure compliance with international (ICH, EMA), and U.S. (CFR, FDA, OSHA) regulations and ensure adherence to all company policies and procedures relating to cGMPs, EH&S practices, etc.

Requirements:

• Minimum BS required, degree in packaging engineering, industrial or mechanical engineering, or similar field.
• 5-10 years' packaging experience in the biopharmaceutical industry with knowledge of biologics manufacturing and aseptic processing.

• Must have experience with packaging design/development, finished product manufacturing process development, technical aspects of label design, content management, and labeling graphics design.

• Must have knowledge of applicable Quality and Regulatory guidelines including combination product and device development design controls.
• Prior experience managing third party CMO relationships and as person-in-plant during manufacturing runs.
• Ability to travel domestically and internationally, up to 25%.