Hybrid Associate Director, Engineering – Small Molecule

at MSD

• Job title: Associate Director, Engineering – Small Molecule
• Job type: Full Time
• Experience level: Senior
• Salary: $129,000 - $203,100 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, United States

About the role

• Associate Director leading packaging development for small molecule products, collaborating across CMC areas and ensuring compliance with regulatory standards. Responsible for defining and executing overall packaging strategies.

Responsibilities

• 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
• accountable for the definition and execution of overall packaging strategies that meet global network needs
• ensuring packaging system designs are robust, packaging processes are efficient, and control strategies are integrated with both upstream and downstream needs
• driving 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

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, and compassionate and sick days