Director, Packaging Distribution, Components and Systems Centers of Excellence (Director, Engineering)

Reporting into the Executive Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for technical leadership, strategic planning and portfolio execution of key work in support of Centers of Excellence for the packaging and device community including logistics and distribution technologies, small molecule bulk and primary packaging components and packaging master data and systems.

The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering robust and pragmatic technical solutions to accelerate the commercialization of new products, and ensuring an uninterrupted, compliant supply of commercialized products for the benefit of patients. The Director of Packaging Distribution, Components and Systems COE is integral to this mission. The successful candidate will possess deep packaging and/or combination product technical expertise, a strong track record in problem-solving, strategic acumen, and execution, along with exceptional leadership skills to shape the technical capabilities and strategic direction for a global, cross-modality technical team.

The Director will lead a team of technical experts responsible providing Center of Excellence support to the enterprise. They will be responsible for executing the organization's priorities and ensuring the successful completion of projects. This includes providing SME guidance to the enterprise for logistics and distribution technologies including thermal container qualification from frozen through refrigerated to room temperature shipments, distribution (shock and vibration) qualification, and data collection systems for distribution (e.g. temperature monitors). To provide SME guidance in support of small molecule drug substance and drug product container closure systems including mold qualification and regulatory compliance. To act as master data stewards and support enterprise wide component specification management as well as maintaining documentation systems for the packaging community. The COE teams provide support to life cycle changes, investigations, trouble shooting and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external networks

The candidate is expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and manufacturing sites, supply chain, commercialization teams across the end to end supply chain, and analytical, regulatory, and project leaders. The successful candidate will demonstrate ownership and make informed cost/benefit decisions based on the analysis of inputs, outcomes, risks, and company-wide prioritization.

Essential 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 distribution, component and systems COE portfolio, including interrogation of the data/ science through technical reviews and exploring alternative ways to view and solve problems to achieve results
• Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies.
• Collaborate with cross-functional teams and stakeholders to ensure that all solutions (e.g. thermal containers, package designs, new components) meet safety, efficacy, quality, and robust supply standards.
• Develop and maintain strong relationships with internal stakeholders, including supply chain, packaging commercialization, quality, analytical, regulatory, manufacturing, Device Development and Technology, to facilitate effective COE support to the portfolio. This includes above site support for significant investigations, developing new solutions, establishing guidance and standard work. and maintaining key systems including component specifications.
• Provide strategic leadership and direction for technical support across Centers of Excellence including technical guidance to component or process changes, supporting tech transfers and investigations.
• Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of COE support. Manage the portfolio of work in the platform, holding the team accountable to deliver on priorities on time and right first time.
• Ensure thorough engineering and packaging science is applied to deliverables.

Minimum Education Requirements and Experience:

• Bachelor of Science (BS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years relevant experience pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR
• Master of Science (MS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with twelve (12) years relevant experience pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR
• PhD in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years relevant experience pharmaceutical packaging, combination product assembly and packaging, or related technical fields

Required Skills and Experience:

• Subject matter expertise in packaging and/or medical device and combination product components as well as development and qualification of package design and/or distribution/ transportation technologies for pharmaceutical products. Demonstrated depth in commercialization and tech transfer, assembly and packaging process improvement and support from early stage through launch and supply, including components, process, and equipment, as well as qualification and validation.
• Demonstrated experience in a leadership role; managing technical teams supporting packaging and/or combination product assembly and packaging.
• Strong problem-solving and decision-making skills with an ability to determine interrogate the science, identify true requirements, and detect critical flaws including the ability to determine areas of potential risk, generate gap analysis and mitigation strategies
• In-depth knowledge of global regulatory requirements for medical devices and combination products and packaging, including Good Distribution Practices (cGDP) as well as thermal and distribution qualification for pharmaceutical products.
• Strong understanding of risk management principles.
• 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:
Applied Mathematics, Applied Mathematics, Business, Client-Focused, Client Relationship Building, Compliance Packaging, Confidentiality, Continual Improvement Process, Driving Continuous Improvement, Effective Listening, Engineering Standards, Key Performance Indicators (KPI), Leading International Teams, Management Process, Manufacturing Scale-Up, Medical Device Regulations, Medical Devices, Packaging Engineering, Packaging Innovation, Packaging Technologies, People Leadership, Pharmaceutical Packaging, Risk Communications, Risk Evaluation And Mitigation Strategy (REMS), Risk Management {+ 5 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. 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 applicable 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:

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We are proud to be a company that embraces the value of bringing together, talented, and committed 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.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$169,700.00 - $267,200.00

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 .

You can apply for this role through (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:
01/1/2026
*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.

Requisition ID: R360277