Associate Director, Engineering- Packaging Commercialization

The Associate Director, Engineering, Packaging Commercialization will lead packaging development for new products including parenteral products including small molecules, biologics, vaccines and oral solid dosage. This role involves collaborating with stakeholders across the end-to-end continuum of CMC areas and requires both an understanding of packaging as well as prior expThe Associate Director will be accountable for the definition and execution of overall packaging strategies that meet global network needs. Responsibilities include ensuring packaging system designs are robust, packaging processes are efficient, and control strategies are integrated with both upstream and downstream needs. They will ensure activities supporting these program deliverables are executed with technical rigor and drive risk understanding and reduction prior to product launch. The packaging development lead will be accountable for technical risk assessments, packaging specifications, and qualification activities, while ensuring compliance with all regulatory standards and sustainability goals. Individuals in this role will lead with ownership and accountability for representing, communicating, and balancing the interests of stakeholders. They will have an ability to effectively drive the right risk posture that balances technical probability, cost and resources, and trade-offs across various groups. The role requires strong technical skills, problem-solving abilities, and the capacity to navigate complex situations in a fast-paced environment, all while aligning packaging with product and patient needs.**Minimum Education Requirement and Experience:**Bachelor of Science (B.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with ten (10) years of relevant pharmaceutical development experience; Master of Science (M.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with eight (8) years of relevant pharmaceutical development experience; PhD in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with five (5) years of relevant pharmaceutical development experience**Required Experience and Skills:** Demonstrated understanding ofpharmaceutical development process and ability to design, develop, and test primary and secondary packaging componentsDemonstrated ability to work both independently and as part of a larger team Demonstratedexperience in leading cross-functional groups both internally and externallyDemonstrated project management experience and ability to provide technical leadership for complex projects while managing multiple projects in a fast-paced environment Excellenttechnical written and oral communication skills that support presentation of information clearly and concisely for all levels of the organizationDemonstrated knowledge of current US, and global Regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging Strong interpersonal skills and the demonstrated ability to influence senior leaders Ability to manage complex programs and support multiple activities/projects **Preferred Experience and Skills:** Medical Device and Combination Product Packaging development experience Quality by Design (QbD) experienceExperience in defining standard work processes and documents.Experience specifying, processing and characterizing packaging materials including rigid and flexible barriers, pulp/paperboard and recyclables.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr