Associate Director, Engineering- Small Molecule
Merck, Rahway, NJ, United States
Job Description
Reporting to the Director of Packaging Commercialization, the Associate Director, Engineering, Packaging Commercialization will lead packaging development for new oral solid dosage and parenteral products in our small molecule portfolio.
This role involves collaborating with stakeholders across the end‑to‑end continuum of CMC areas and requires both an understanding of packaging as well as prior experience developing and commercializing new products on cross‑functional teams.
The Associate Director will be accountable for the definition and execution of 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 be accountable for technical risk assessments, packaging specifications, and qualification activities, while ensuring compliance with all regulatory standards and sustainability goals. Individuals in this role will lead with ownership and accountability for representing, communicating, and balancing the interests of stakeholders. They will have an ability to effectively drive the right risk posture that balances technical probability, cost and resources, and trade‑offs across various 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 Requirements 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;
Master of Science (M.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with eight (8) years of relevant pharmaceutical development experience.
Required Experience and Skills
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
Preferred Experience and Skills
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
Compliance Packaging
Cross‑Functional Teamwork
Engineering Standards
Good Manufacturing Practices (GMP)
Leadership
Packaging Engineering
Packaging Processes
Pharmaceutical Development
Process Optimization Preferred Skills Current Employees apply HERE
Current Contingent Workers apply HERE
U.S. Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a hybrid schedule consisting of three total days on‑site per week, Monday‑Thursday, with Friday designated as a remote‑working day, unless business‑critical tasks require an on‑site presence. This model does not apply to field‑based, facility‑based, or research‑based positions located at a Company site; nor to positions covered by a collective‑bargaining agreement unless the agreement provides for hybrid work; or to any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note that this hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Compensation and Benefits Salary range for this role: $129,000.00 – $203,100.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including 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.
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 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.
We are proud to be a company that embraces the value of bringing together talented, dedicated 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 your rights, including under California, Colorado and other U.S. State Acts.
Application Information You can apply for this role through https://jobs.merck.com/us/en/ (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
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.
Recruiting Merck & Co., Inc., Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms without a valid written search agreement in place for this position will be deemed the sole property of the company. No fee will be paid in the event a candidate is hired by the company as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific.
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
Job Posting End Date 04/7/2026
A job posting is effective until 11:59:59 PM 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 R381108
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This role involves collaborating with stakeholders across the end‑to‑end continuum of CMC areas and requires both an understanding of packaging as well as prior experience developing and commercializing new products on cross‑functional teams.
The Associate Director will be accountable for the definition and execution of 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 be accountable for technical risk assessments, packaging specifications, and qualification activities, while ensuring compliance with all regulatory standards and sustainability goals. Individuals in this role will lead with ownership and accountability for representing, communicating, and balancing the interests of stakeholders. They will have an ability to effectively drive the right risk posture that balances technical probability, cost and resources, and trade‑offs across various 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 Requirements 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;
Master of Science (M.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with eight (8) years of relevant pharmaceutical development experience.
Required Experience and Skills
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
Preferred Experience and Skills
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
Compliance Packaging
Cross‑Functional Teamwork
Engineering Standards
Good Manufacturing Practices (GMP)
Leadership
Packaging Engineering
Packaging Processes
Pharmaceutical Development
Process Optimization Preferred Skills Current Employees apply HERE
Current Contingent Workers apply HERE
U.S. Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a hybrid schedule consisting of three total days on‑site per week, Monday‑Thursday, with Friday designated as a remote‑working day, unless business‑critical tasks require an on‑site presence. This model does not apply to field‑based, facility‑based, or research‑based positions located at a Company site; nor to positions covered by a collective‑bargaining agreement unless the agreement provides for hybrid work; or to any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note that this hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Compensation and Benefits Salary range for this role: $129,000.00 – $203,100.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including 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.
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 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.
We are proud to be a company that embraces the value of bringing together talented, dedicated 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 your rights, including under California, Colorado and other U.S. State Acts.
Application Information You can apply for this role through https://jobs.merck.com/us/en/ (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
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.
Recruiting Merck & Co., Inc., Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms without a valid written search agreement in place for this position will be deemed the sole property of the company. No fee will be paid in the event a candidate is hired by the company as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific.
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
Job Posting End Date 04/7/2026
A job posting is effective until 11:59:59 PM 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 R381108
#J-18808-Ljbffr