POSITION OBJECTIVE: The Packaging Project Manager role is an integral part of the CMC team and is responsible for the development and engineering of new, innovative packaging solutions.
Essential Job Functions/Responsibilities
· Responsible for aspects of project management from feasibility, planning, design, construction, commissioning and handover and ensures that all key project performance objectives are met regarding efficiencies, waste, throughput and staffing, as well as delivering the project on schedule within the budgetary limits.
· Support the conceptualization, initiation, design, development and implementation of new and improved packaging systems including design generation, prototype development, engineering specifications, component qualification, vendor evaluation, functionality and quality testing, commissioning and technology transfer.
· Identify and implement cost saving initiatives related to packaging materials, labor, efficiency, transportation, and storage.
· Create project cost and savings estimates, tooling/package qualification plans, final package component specifications, Bills of Materials and equipment specifications.
· Support implementation and support for new product launches, cost savings & operations efficiency initiatives, and quality investigations.
· Responsible for technology transfer from Engineering to Operations to ensure new packaging systems perform as designed and meets all performance targets.
· Understand, interpret and refine package testing procedures and standards to support the effective design, validation, and implementation of new packages and packaging technology.
· Establish trial protocol to ensure package and/or equipment performs as specified and meets all project success criteria.
· Material knowledge in pharmaceutical packaging, flexible films, folding cartons, paper related substrates, corrugated, and rigid packaging
· Establish FAT requirements for equipment and systems, attends FAT testing and approves equipment for delivery to the project site.
· Collaborate closely with all cross functional project team members and stakeholders.
· Ensure project financial objectives are met while maintaining compliance with all internal and external regulations.
· Writes internal procedures required to ensure cGMP compliance.
· Prepares related documents for regulatory filings.
· Provide support to physical & cold chain shipping studies, line trial, packaging material qualifications, child resistant requirements, human factor studies and patient centric design.
Required Education & Qualifications
· Bachelor’s degree in related field, required
· 5 - 10 years of experience in package development/engineering in the pharmaceutical industry, required
· Must have proven experience in packing line design, performance specifications, and testing protocols.
· Strong project management skills.
· Experience conducting design reviews.
· Strong analytical thinking, problem solving skills and an aptitude for detail required and a proven track record of demonstrable leadership qualities a must.
· Must have strong communication and organizational skills, including the ability to facilitate meetings and communicate outcomes, prepare progress reports and track project financials, and develop presentations and present in a cross functional environment to internal and external audiences.
· Strong interpersonal skills, managing relationships with internal customers and vendors.
· Experience with pharmaceutical regulations, cGMP, risk analysis, FMEAs, design controls and sanitary design best practices
· Manage multiple projects simultaneously.
· Travel requirements will vary depending on project location but will require full time presence on site during the project construction and commissioning/handover phases.
· Experience in solid dose packaging is preferred
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.