Director, Global Distribution Engineering and Technology

Merck & Co.•West Point, PA

50d•Hybrid

About The Position

Director, Packaging Shipping Systems (Logistics and Distribution Technology) Reporting into the Director Packaging Distribution, Components and Systems COE, the Director, Global Distribution Engineering and Technology, will be responsible and accountable for subject matter expert technical support for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally. 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 Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep 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 Logistics and Distribution Technology Center of Excellence support to the enterprise. The leader will be responsible for executing the organization's priorities and ensuring the successful completion of projects. This includes technical support to the internal and external manufacturing sites as well as Third Party Logistics providers to ensure robust, compliant distribution of products through guidance on distribution qualification activities for shock and vibration as well as thermal protection system testing and qualification and leading execution of qualification of complex systems. In addition, characterizing the real-world distribution experience to enable translation into standard work development for distribution related characterization across packaging platforms to ensure protective packaging designs. The candidate is expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and 3rd party logistics sites, supply chain and technology teams, and 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.

Requirements

Bachelor of Science (BS) in packaging, mechanical, chemical, biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years of required experience in 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 of required experience in 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 of required experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields
Subject matter expertise in distribution technologies (e.g. cold-chain, thermal protection systems, temperature profiles, monitoring technologies, shock, and vibration), processes and operations across internal and external partners and third-party logistics providers.
Subject matter expertise in development and qualification of package design and/or distribution/ transportation technologies for pharmaceutical products including parenteral and/or medical device and combination products.
Demonstrated experience in a leadership role, managing technical team in support of packaging or distribution operations, or related functions.
Strong problem-solving and decision-making skills with an ability to interrogate the science, identify true requirements, and detect critical flaws including ability to determine areas of potential risk, generate gap analysis and mitigation strategies
In-depth knowledge of global regulatory requirements for distribution including good distribution practices. Able to guide key activities including development of standard work, investigations, and problem solving
Strong strategic and analytical thinking, with a focus on driving continuous improvement and implementing best practices in technical support.
Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.
Biopharmaceutics
Business
Change Management
Combination Products
Compliance Packaging
Cross-Cultural Awareness
Data-Driven Decision Making
Design Verification Testing
Distribution Operations
Distribution Strategies
Driving Continuous Improvement
Engineering Standards
Immunochemistry
Key Performance Indicators (KPI)
Leadership Project Management
Management Process
Manufacturing Scale-Up
Mentorship
New Product Introduction Process
Packaging Engineering
Packaging Equipment
Pharmaceutical Packaging
Risk Assessments
Risk Communications

Nice To Haves

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: EEOC Know Your Rights EEOC GINA Supplement
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.
Learn more about your rights, including under California, Colorado and other US State Acts
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”.
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

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 portfolio, including interrogation of the data/ science through technical reviews and exploring alternative ways to view and solve problems to achieve results.
Provide strategic leadership and direction for development of standard work to characterize the real-world distribution environment, and to translate that into distribution related characterization of packaging systems.
Ensure thorough engineering and distribution packaging science is applied to deliverables for new product introductions and technology transfers across the network.
Deliver the development, design, construction, qualification/ validation and/or initial operation of complex tertiary packaging components and processes, including environmental (temperature, shock, etc.) monitors, using new or existing technologies for new and commercial human health products including active pharmaceutical ingredients, drug substance, drug product, finished goods including combination products, and samples.
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 platforms meet safety, efficacy, quality, and robust supply standards.
Develop and maintain strong relationships with internal stakeholders, including commercialization, quality, analytical, regulatory, manufacturing, and Supply Chain to facilitate effective technical support. This includes above site support for significant investigations, complaints monitoring and rapid response activities.
Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of COE support.
Manage a portfolio of work, holding the team accountable to deliver on priorities
Remain informed of current Good Manufacturing Practices, cGMP, and Good Distribution Practices, cGDP, and requirements and industry trends as described in worldwide regulations and industry standards

Benefits

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

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume