Jobbeschreibung

Positionsnummer / Reference Number

PA2205511122018

Position / Job Title

Director Packaging & Labeling

Aufgaben / Tasks

• Support successful commercial launch of products by providing packaging vendor selection, oversight, artwork development, validation strategy, and product track and trace solutions
• Bring and develop packaging expertise into the organization and function as a key communication interface between Sales/Marketing, Manufacturing, Quality, Regulatory, external suppliers, and consultants in the development and execution of packaging strategies
• Interface with internal and external stakeholders to implement and validate product track and trace solutions
• Oversee validation work at contract packagers as related to packaging and integration of new processes or equipment
• Troubleshoot packaging problems, document findings and implement solutions to resolve problems.
• Coordinate with commercial Supply Chain, Manufacturing, Regulatory, and QA to ensure timely release and shipment of packaged product to Commercial Distributors
• Assist the supply chain team with sourcing of 3PLs and other contract-based service providers
• Assist Supply Chain and engineering to develop packaging options that best meet the needs of the trial design while satisfying product requirements
• Author packaging related sections of regulatory submissions
• Support the Validation of kit packaging, to include ISTA shock & vibration testing
• Prepare and deliver development reports, protocols, batch records, and SOPs supporting packaging development and regulatory submissions

Qualifikationen / Qualifications

• BS or MS in engineering or life sciences, with 8+ years of biopharmaceutical experience or consumer goods in a packaging, engineering, and validations environment
• 10+ years of experience in a packaging and artwork development in an FMCG or healthcare environment.
• Comprehensive working knowledge of FDA, USP and ICH guidelines (MDR knowledge is a plus)
• Familiarity with and experience in applying global regulatory requirements for packaging and labeling of commercial and medical products
• Expertise in computer skills: Microsoft Word/Excel/PowerPoint, Project/Visio
• Working knowledge of ERP and PLM systems and drug product track trace systems is highly desirable but not required
• Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues in a virtual environment
• Flexibility and the ability to manage changing needs
• Exceptional verbal and written communication skills

Weitere Informationen / Further Information

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