Onsite
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 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
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, Project Management, Root Cause Analysis (RCA), Small Molecules, Technical LeadershipPreferred Skills:
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The salary range for this role is
$129,000.00 - $203,100.00This 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.
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.
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
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our 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. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
06/4/2026*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.
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