 We are seeking an Associate Director, Packaging Engineering and Commercial Labeling, who will be responsible for leading and managing the global packaging and labeling service for Commercial Supply, including activities related to new product introductions. This role will work with our packaging vendors, to define commercial packaging, product labeling and critical package requirements for new commercial products and potential changes or process improvements in our current commercial product. This position will also be responsible for overseeing the operational aspects of commercial supply labeling, including serialization, label copy, draft labeling, prooing, electronic and hard copy file maintenance, and distribution of approved materials. The position will be required to work closely with several functional departments including Technical Operations, Commercial Operations, Marketing, Quality Assurance, Regulatory Affairs and Third-Party Vendors, CMOs (Commercial Packaging Vendors and Print Vendors).This position will report to the Director, Supply Chain Operations and may be a remote position or located in the Waltham, MA office.What You'll Do:SME in packaging and labeling, ensuring proper packaging operations are established for our vendors, packaging specifications and draft labeling specs Develop, lead, and implement optimal packaging solutions along with ensuring proper testing and analysis to assess the packaging’s performance, including durability, safety and environmental impact, globally.Work with our commercial label vendor to manage the creation and revision of labeling for product labels globally, packaging materials, and instructions for use that meet medical, legal, and regulatory requirements.Work with Regulatory Affairs and Quality Assurance on label copy changes and inventory management of packaging material post approval.Responsible for proper serialization coding, barcoding and GTIN numbers globally, per current regulations and standards.Develop, establish, and maintain global packaging standards (die lines, process, compliance) leveraging internal and external capabilities.Manage the specifications, pack specs, change controls, version controls and SOPs related to commercial packaging and labeling.Manage day to day activities with our commercial packager(s).Work with MS&T DP on development of new packaging components for late-stage programs.Assist regulatory team with NDC coding, NDA module writing, draft labeling process and monitoring FDA and global guidelines and requirements for label control.Lead and manage technical transfers, validations and qualifications of packaging lines, new CPOs or site to site transfers.Work with the commercial packager to determine appropriate batch size and process improvements.Set commercial packaging KPIs.Manage QBR’s etc., and building vendor relationshipsParticipate in new packaging vendor selection processImplement validation of the supply chain MRP system in Oracle
