Packaging Technical Lead (Associate Director)

Merck & Co.; Rahway (NJ); On-site; USD 129,000 - 203,000; Full time

Job summary

Merck in Rahway, NJ is seeking an Associate Director, Packaging to define and execute packaging strategies that meet global network needs. You will lead cross-functional teams across CMC, collaborate with suppliers, and drive risk assessment and qualification activities for primary and secondary packaging components.

The role requires a BS in Packaging Engineering or related field with 10 years of pharma development experience, or an MS/PhD with 8 years, and strong knowledge of regulatory

Qualifications

• BS in Packaging Engineering, Packaging Science, Mechanical Eng, or similar; 10 years pharma development; OR MS/PhD with 8 years.
• Understanding of pharmaceutical development process and ability to design, develop, and test primary/secondary packaging components.
• Understanding of Risk Assessment tools.
• Ability to work independently and in teams.
• Experience leading cross-functional groups; BFS packaging experience; project management and leadership.

Responsibilities

• Ensure packaging designs are robust and processes efficient; control strategies aligned with upstream/downstream needs.
• Drive risk assessment and reduction prior to product launch.
• Oversee qualification activities and develop packaging specs.
• Ensure compliance with regulatory standards and sustainability goals.
• Collaborate across end-to-end CMC areas and drive cross-functional teamwork.

Skills

Packaging Engineering

Cross-functional Leadership

Risk Assessment

GMP Knowledge

Regulatory Knowledge

Project Management

Communication Skills

Education

BS in Packaging Engineering or related field

MS/PhD in related field

Tools

Blow-fill-seal (BFS) Packaging

Job description

Job Description

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. We are seeking an Associate Director, Packaging, to join our team and lead the definition and execution of overall packaging strategies that meet global network needs.

Responsibilities

• Ensure packaging system designs are robust, packaging processes are efficient, and control strategies are integrated with both upstream and downstream needs.
• Drive risk understanding and reduction prior to product launch.
• Conduct technical risk assessments, develop packaging specifications, and oversee qualification activities.
• Ensure compliance with all regulatory standards and sustainability goals.
• Represent, communicate, and balance the interests of stakeholders.
• Drive the right risk posture that balances technical probability, cost, resources, and trade-offs across various groups.
• Collaborate with stakeholders across the end-to-end continuum of CMC areas.
• Develop and commercialize new products on cross-functional teams.

Qualifications

Required

• 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 MS/PhD with 8 years
• 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.
• Ability to work both independently and as part of a larger team.
• Experience in leading cross-functional groups both internally and externally.
• Experience with blow-fill-seal technologies for sterile pharmaceutical packaging systems.
• 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.
• Knowledge of current US and global Regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging.
• Strong interpersonal skills and the 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.

Preferred

• Medical Device and Combination Product Packaging development experience.
• Quality Risk Management, Risk-Based Decision Making, and Quality by Design (QbD) experience.
• Experience in defining standard work processes and documents.
• Experience specifying, processing, and characterizing packaging materials including rigid and flexible barriers, pulp/paperboard, and recyclables.

Required Skills

Ability to Coordinate, Ability to Coordinate, Change Management, Collaborative Leadership, Combination Products, Competency Management, Compliance Packaging, Cross-Functional Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, Global Coordination, Good Manufacturing Practices (GMP), Group Processes, ISO Compliance, Legal Compliance, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Procedure Writing, Process Definition, Process Optimization, Project Leadership, Project Management Leadership, Project Team Management {+ 10 more}

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

Equal Employment Opportunity

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 the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement.

Company Culture

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn More About Rights

Learn more about your rights, including under California, Colorado and other US State Acts.

Salary Range

The salary range for this role is $129,000.00 - $203,100.00.

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits.- Available benefits include 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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Application Process

The application deadline for this position is stated on this posting.

San Francisco Residents Only

We are committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

25%

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

10/21/2026

A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R420807