Merck
Associate Director, Engineering- Packaging Commercialization
Merck, West Point, Nebraska, United States, 68788
Overview
The Associate Director, Engineering, Packaging Commercialization will lead packaging development for new products including parenteral products, small molecules, biologics, vaccines and oral solid dosage. This role collaborates with stakeholders across the end-to-end CMC continuum, requiring both packaging expertise and experience developing and commercializing new products on cross-functional teams.
Key Responsibilities
Define and execute overall packaging strategies that meet global network needs.
Design robust packaging systems and ensure packaging processes are efficient; integrate control strategies with upstream and downstream needs.
Lead technical risk assessments, packaging specifications, and qualification activities while ensuring regulatory compliance and sustainability goals.
Represent, communicate, and balance the interests of stakeholders; drive an appropriate risk posture balancing technical probability, cost, resources, and trade-offs across groups.
Provide technical leadership in complex programs, manage multiple projects in a fast-paced environment, and work effectively with cross-functional internal and external teams.
Demonstrate strong technical communication skills for all levels of the organization.
Minimum Education Requirement and Experience
Bachelor of Science in Packaging Engineering, Packaging Science, Mechanical Engineering, or related field with ten (10) years of relevant pharmaceutical development experience OR
Master of Science in Packaging Engineering, Packaging Science, Mechanical Engineering, or related field with eight (8) years of relevant pharmaceutical development experience OR
PhD in Packaging Engineering, Packaging Science, Mechanical Engineering, or related field with five (5) years of relevant pharmaceutical development experience.
Required Experience and Skills
Understanding of the pharmaceutical development process and ability to design, develop, and test primary and secondary packaging components.
Knowledge of Medical Device and Combination Product regulations.
Experience with risk assessment tools.
Ability to work independently and as part of a team.
Experience leading cross-functional groups internally and externally.
Project management experience with the ability to lead technical work across multiple projects in a fast-paced environment.
Excellent technical written and oral communication skills for all organizational levels.
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 Experience and Skills
Medical Device and Combination Product packaging development experience.
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.
Current Employees apply here. Current Contingent Workers apply here.
Additional Information US and Puerto Rico Residents Only:
Our company is committed to inclusion. Please indicate if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination. We comply with applicable 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 Know Your Rights and EEOC GINA Supplement pages.
We are committed to an inclusive environment and encourage diverse perspectives to drive innovation.
U.S. Hybrid Work Model:
Effective September 5, 2023, employees in office-based positions in the U.S. will follow a Hybrid model (three on-site days per week, with some site variations). Certain roles are remote or field-based and may have different requirements.
Salary:
The salary range for this role is $126,500.00 - $199,100.00. Final compensation will be based on factors including education, experience, location, and business needs.
Benefits:
We offer comprehensive benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick days. More information is available at the company compensation and benefits page.
Application:
You can apply through the company careers site. The application deadline is stated in the posting.
Travel Requirements:
10%
Shift:
1st - Day
Hybrid/Remote:
Hybrid
Job Posting End Date:
10/7/2025
#J-18808-Ljbffr
Key Responsibilities
Define and execute overall packaging strategies that meet global network needs.
Design robust packaging systems and ensure packaging processes are efficient; integrate control strategies with upstream and downstream needs.
Lead technical risk assessments, packaging specifications, and qualification activities while ensuring regulatory compliance and sustainability goals.
Represent, communicate, and balance the interests of stakeholders; drive an appropriate risk posture balancing technical probability, cost, resources, and trade-offs across groups.
Provide technical leadership in complex programs, manage multiple projects in a fast-paced environment, and work effectively with cross-functional internal and external teams.
Demonstrate strong technical communication skills for all levels of the organization.
Minimum Education Requirement and Experience
Bachelor of Science in Packaging Engineering, Packaging Science, Mechanical Engineering, or related field with ten (10) years of relevant pharmaceutical development experience OR
Master of Science in Packaging Engineering, Packaging Science, Mechanical Engineering, or related field with eight (8) years of relevant pharmaceutical development experience OR
PhD in Packaging Engineering, Packaging Science, Mechanical Engineering, or related field with five (5) years of relevant pharmaceutical development experience.
Required Experience and Skills
Understanding of the pharmaceutical development process and ability to design, develop, and test primary and secondary packaging components.
Knowledge of Medical Device and Combination Product regulations.
Experience with risk assessment tools.
Ability to work independently and as part of a team.
Experience leading cross-functional groups internally and externally.
Project management experience with the ability to lead technical work across multiple projects in a fast-paced environment.
Excellent technical written and oral communication skills for all organizational levels.
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 Experience and Skills
Medical Device and Combination Product packaging development experience.
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.
Current Employees apply here. Current Contingent Workers apply here.
Additional Information US and Puerto Rico Residents Only:
Our company is committed to inclusion. Please indicate if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination. We comply with applicable 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 Know Your Rights and EEOC GINA Supplement pages.
We are committed to an inclusive environment and encourage diverse perspectives to drive innovation.
U.S. Hybrid Work Model:
Effective September 5, 2023, employees in office-based positions in the U.S. will follow a Hybrid model (three on-site days per week, with some site variations). Certain roles are remote or field-based and may have different requirements.
Salary:
The salary range for this role is $126,500.00 - $199,100.00. Final compensation will be based on factors including education, experience, location, and business needs.
Benefits:
We offer comprehensive benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick days. More information is available at the company compensation and benefits page.
Application:
You can apply through the company careers site. The application deadline is stated in the posting.
Travel Requirements:
10%
Shift:
1st - Day
Hybrid/Remote:
Hybrid
Job Posting End Date:
10/7/2025
#J-18808-Ljbffr