Job DescriptionDirector Packaging and Assembly Platform Technical LeadershipThe Director, Packaging & Assembly Platform Technical Leadership, provides strategic and scientific leadership for the development, commercialization, and lifecycle stewardship of pharmaceutical and combination-product packaging platforms. This role ensures robust technical execution, compliant global submissions, and optimized manufacturing performance through expert guidance, risk management, and cross-functional collaboration.
Responsibilities- Lead, mentor, and develop a team of technical staff, fostering a culture of continuous improvement.
- Provide subject matter expertise and ensure scientific rigor, technical problem solving, and execution excellence across the assembly and packaging platform portfolio.
- Develop and execute robust technical plans across device assembly, packaging, and/or distribution and logistics of finished goods images Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies.
- Provide technical guidance to investigations and lifecycle changes for packaging platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards.
- Provide technical guidance to platform standards for standard finished goods images and packaging and assembly equipment standards
- Drive continuous improvement initiatives
- Develop and maintain strong relationships with internal stakeholders to facilitate effective technical support and platform stewardship.
- Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of technical platform stewardship activities. Provide strategic leadership and direction for technical support across the platform stewardship teams.
QualificationsRequired
- Bachelor of Science (BS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years required experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR MS with twelve (12) years OR PhD with eight (8) years
- Subject matter expertise in medical device and combination product (MDCP) assembly and packaging, including primary and secondary packaging formats such as bottles, blisters, and prefilled syringes (PFS), with experience spanning process development, scale-up, validation, and commercialization.
- Experience leading or supporting global technical transfers of combination product assembly and packaging processes, including scale-up, PPQ readiness, and cross-site implementation.
- Demonstrated experience in a leadership role; managing technical teams supporting packaging as well as combination product assembly & packaging.
- Strong technical problem-solving capability with experience in root cause analysis, process optimization, and troubleshooting of automated or high-speed assembly and packaging systems, including integration of device and packaging processes.
- In-depth knowledge of global regulatory requirements and design controls for medical devices and combination products, including integration of device design, packaging performance, and regulatory submissions (e.g., human factors, extractables/leachables, stability considerations).
- Strong technical knowledge of automated and semi-automated assembly systems, including AI-enabled inspection technologies, vision systems, and smart manufacturing solutions supporting combination product assembly and packaging.
- Demonstrated expertise across diverse packaging formats and materials, including rigid containers, blister systems, and injectable device formats, with understanding of material compatibility, sterility assurance, and product integrity requirements.
- Strong understanding of risk management principles, including ISO14971 and other relevant standards.
- Strong strategic and analytical thinking, with a focus on driving continuous improvement and implementing best practices in technical support and product stewardship.
- Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.
Required Skills: Accountability, Accountability, Change Management, Cold Chain, Cold Chain Logistics, Cold Chain Management, Cold Chain Packaging, Combination Products, Compliance Packaging, Cross-Cultural Awareness, Data-Driven Decision Making, Design Verification Testing, Distribution Network Optimization, Domestic Corporate Compliance, Driving Continuous Improvement, Engineering Standards, GMP Compliance, Gross Domestic Product, Innovation, Leadership, Leadership Project Management, Manufacturing Scale-Up, Materials Design, Materials Engineering, Mentorship {+ 10 more}
Preferred Skills: Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:The salary range for this role is
$156,900.00 - $247,000.00
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.
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
Search Firm Representatives Please Read Carefully 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: Regular
Relocation:Domestic
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:07/1/2026
*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. 
