Associate Director, Engineering – Small Molecule

Role Overview

• Reporting to the Director of Packaging Commercialization, the Associate Director, Engineering, Packaging Commercialization will lead packaging development for new oral solid dosage and parenteral products in our small molecule portfolio.
• Collaborating with stakeholders across the end-to-end continuum of CMC areas and requires both an understanding of packaging as well as prior experience developing and commercializing new products on cross-functional teams.
• 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.
• Ensure activities supporting these program deliverables are executed with technical rigor and drive risk understanding and reduction prior to product launch.
• Accountable for technical risk assessments, packaging specifications, and qualification activities, while ensuring compliance with all regulatory standards and sustainability goals.
• Lead with ownership and accountability for representing, communicating, and balancing the interests of stakeholders.
• Drive the right risk posture that balances technical probability, cost and resources, and trade-offs across various groups.
• 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.

Requirements

• Bachelor of Science (B.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with ten (10) years of relevant pharmaceutical development experience; OR Master of Science (M.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with eight (8) years of relevant pharmaceutical development experience
• Small molecule portfolio leadership, with experience supporting small molecule portfolio across oral solid dosage forms (tablets, capsules)
• Demonstrated understanding of pharmaceutical development process and ability to design, develop, and test primary and secondary packaging components
• Demonstrated understanding of the use of Risk Assessment tools
• Demonstrated ability to work both independently and as part of a larger team
• Demonstrated experience in leading cross-functional groups both internally and externally
• Demonstrated project management experience and ability to provide technical leadership for complex projects while managing multiple projects in a fast-paced environment
• Excellent technical written and oral communication skills that support presentation of information clearly and concisely for all levels of the organization
• Demonstrated 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
• Willingness to grow and learn all areas of Pharmaceutical new product development

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days