Consultant - Packaging & Labeling

Summary: The role serves as the primary interface between Immunic and the CMO to ensure all packaging, labeling, serialization, validation, and launch activities are executed in accordance with regulatory requirements, quality expectations, and commercial launch timelines. Please note this is a contract position, we are looking for someone for 40h/week, project duration appr. 6 months. Key Responsibilities: Providing expert sponsor oversight of CMO packaging activities. Ensuring packaging operations support US commercial launch requirements. Managing technical interactions with packaging and serialization vendors. Reviewing and approving packaging validation strategies. Monitoring project timelines and launch risks. Driving timely resolution of technical and operational issues. Providing routine updates to Immunic management. Qualification & Education: 10+ years in pharmaceutical packaging operations and development. Strong experience with commercial bottling and labeling of solid oral dosage forms. Experience overseeing external packaging CMOs. Extensive knowledge of:Serialization and AggregationPackaging validationPackaging equipment qualificationCommercial launch readinessExperience supporting FDA-regulated commercial products. Strong understanding of U.S. commercial supply chain requirements. Immunic Therapeutics is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status. Please note, Immunic does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Immunic and the agency. Immunic will not pay any fees related to unsolicited resumes.