MSD
Associate Director, Engineering- Packaging Commercialization
MSD, Rahway, New Jersey, us, 07065
Overview
Job Description
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 involves collaborating with stakeholders across the end-to-end continuum of CMC areas and requires both an understanding of packaging and prior experience developing and commercializing new products on cross-functional teams.
The Associate Director will define and execute 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. They will ensure activities supporting these program deliverables are executed with technical rigor and drive risk understanding and reduction prior to product launch. The packaging development lead will own technical risk assessments, packaging specifications, and qualification activities, while ensuring compliance with regulatory standards and sustainability goals. This role represents, communicates, and balances the interests of stakeholders and drives the right risk posture balancing technical probability, cost, resources, and trade-offs across groups. The role 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.
Minimum Education Requirement and Experience
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; OR
PhD in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with five (5) years of relevant pharmaceutical development experience
Required Experience and Skills
Demonstrated understanding of the pharmaceutical development process and ability to design, develop, and test primary and secondary packaging components
Demonstrated understanding of Medical Device and Combination Product regulations
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
Preferred Experience and Skills
Medical Device and Combination Product Packaging development experience
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
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion. Please click here 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 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 legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement.
We value diversity and inclusion and encourage collaboration across experiences and backgrounds.
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will have a Hybrid work model: three on-site days per week, with one remote day, subject to site needs. Some roles require in-person attendance; see posting for specifics.
The salary range for this role is $126,500.00 - $199,100.00. The final offer will depend on qualifications, experience, and location. Eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive benefits package including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and sick days. More information about benefits is available at Merck compensation and benefits.
You can apply for this role through Merck’s career site. The application deadline is stated on this posting.
San Francisco Residents Only:
We will consider qualified applicants with arrest and conviction records in compliance with the San Francisco Fair Chance Ordinance.
Los Angeles Residents Only:
We will consider all qualified applicants in a manner consistent with applicable laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Search Firm Representatives Please Read Carefully: Merck does not accept unsolicited assistance from search firms for employment opportunities. No fee will be paid in the event a candidate is hired through an agency referral lacking a valid written agreement.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Required Skills:
Combination Products, Compliance Packaging, Deviation Management, Engineering Standards, ISO Standard, Management Process, Mechanical Engineering, Medical Device Management, Medical Devices, Packaging Engineering, Packaging Optimization, Packaging Processes, Pharmaceutical Development, Pharmaceutical Packaging, Risk Management, Technical Leadership
Preferred Skills:
-
Job Posting End Date:
10/7/2025
*A job posting is effective until 11:59:59PM on the day before the listed job posting end date.
#J-18808-Ljbffr
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 involves collaborating with stakeholders across the end-to-end continuum of CMC areas and requires both an understanding of packaging and prior experience developing and commercializing new products on cross-functional teams.
The Associate Director will define and execute 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. They will ensure activities supporting these program deliverables are executed with technical rigor and drive risk understanding and reduction prior to product launch. The packaging development lead will own technical risk assessments, packaging specifications, and qualification activities, while ensuring compliance with regulatory standards and sustainability goals. This role represents, communicates, and balances the interests of stakeholders and drives the right risk posture balancing technical probability, cost, resources, and trade-offs across groups. The role 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.
Minimum Education Requirement and Experience
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; OR
PhD in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with five (5) years of relevant pharmaceutical development experience
Required Experience and Skills
Demonstrated understanding of the pharmaceutical development process and ability to design, develop, and test primary and secondary packaging components
Demonstrated understanding of Medical Device and Combination Product regulations
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
Preferred Experience and Skills
Medical Device and Combination Product Packaging development experience
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
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion. Please click here 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 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 legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement.
We value diversity and inclusion and encourage collaboration across experiences and backgrounds.
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will have a Hybrid work model: three on-site days per week, with one remote day, subject to site needs. Some roles require in-person attendance; see posting for specifics.
The salary range for this role is $126,500.00 - $199,100.00. The final offer will depend on qualifications, experience, and location. Eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive benefits package including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and sick days. More information about benefits is available at Merck compensation and benefits.
You can apply for this role through Merck’s career site. The application deadline is stated on this posting.
San Francisco Residents Only:
We will consider qualified applicants with arrest and conviction records in compliance with the San Francisco Fair Chance Ordinance.
Los Angeles Residents Only:
We will consider all qualified applicants in a manner consistent with applicable laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Search Firm Representatives Please Read Carefully: Merck does not accept unsolicited assistance from search firms for employment opportunities. No fee will be paid in the event a candidate is hired through an agency referral lacking a valid written agreement.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Required Skills:
Combination Products, Compliance Packaging, Deviation Management, Engineering Standards, ISO Standard, Management Process, Mechanical Engineering, Medical Device Management, Medical Devices, Packaging Engineering, Packaging Optimization, Packaging Processes, Pharmaceutical Development, Pharmaceutical Packaging, Risk Management, Technical Leadership
Preferred Skills:
-
Job Posting End Date:
10/7/2025
*A job posting is effective until 11:59:59PM on the day before the listed job posting end date.
#J-18808-Ljbffr