Associate Director, Engineering- Molecule

Associate Director, Engineering, Packaging Commercialization

Reporting to the Director of Packaging Commercialization, the Associate Director will lead packaging development for new oral solid dosage and parenteral products in our small molecule portfolio. The role requires collaboration across the end-to-end continuum of CMC activities and a strong background in packaging, product development, and commercial launch.

• Define and execute overall packaging strategies that meet global network needs.
• Ensure packaging system designs are robust, processes are efficient, and control strategies are integrated with both upstream and downstream requirements.
• Execute technical risk assessments, develop packaging specifications, and lead qualification activities.
• Maintain compliance with regulatory standards and sustainability goals.
• Represent and communicate stakeholder interests while balancing technical probability, cost, and resource trade‑offs.
• Drive risk understanding and reduction prior to product launch in a fast‑paced environment.

• B.S. in Packaging Engineering, Packaging Science, Mechanical Engineering, or a related field with ten (10) years of relevant pharmaceutical development experience.
• OR M.S. in the same fields with eight (8) years of relevant pharmaceutical development experience.

• Leadership of small‑molecule portfolio across oral solid dosage forms (tablets, capsules).
• Design, develop, and test primary and secondary packaging components.
• Use of risk assessment tools.
• Ability to work independently and within larger cross‑functional teams.
• Experience leading cross‑functional groups internally and externally.
• Project management experience, providing technical leadership across complex, multi‑project environments.
• Excellent written and oral communication skills.
• Knowledge of U.S. and global regulations, ICH guidance, ISO standards, and pharmaceutical packaging quality systems.
• Strong interpersonal and influence skills with senior leaders.
• Program management and support for multiple concurrent activities.
• Willingness to learn all areas of pharmaceutical new product development.

• Medical device and combination product packaging development experience.
• Quality risk management, risk‑based decision making, and quality by design (QbD) experience.
• Experience defining standard work processes and documents.
• Experience specifying, processing, and characterizing packaging materials, including rigid and flexible barriers, pulp/paperboard, and recyclables.

• Compliance Packaging
• Cross‑Functional Teamwork
• Engineering Standards
• Good Manufacturing Practices (GMP)
• Leadership
• Packaging Engineering
• Packaging Processes
• Pharmaceutical Development
• Process Optimization
• Project Management
• Root Cause Analysis (RCA)
• Small Molecules
• Technical Leadership

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under U.S. Equal Opportunity Employment laws, visit the EEOC website. We are committed to inclusion and diversity in our workforce.

Salary range: $ – $. Bonus eligibility and long‑term incentives are included. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick days. Additional benefits details are available at our benefits page.

Hybrid model:
Employees in U.S. office‑based positions will be working three in‑office days per week (Monday‑Thursday) and one remote day (Friday) unless business needs require otherwise. Roles with field‑, facility‑, or manufacturing‑based requirements are exempt. Remote positions are designated as such.

Location:

Rahway, NJ, USA. Travel: 10%.