Reporting into the Director, Logistics and Distribution Technology the Associate Director, Logistics and Distribution 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, experimental design and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.
The Associate Director will lead a team of technical experts responsible for 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 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.
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.
Essential Responsibilities- Lead, mentor, and develop a team of technical staff, fostering a culture of continuous improvement.
- 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.
- Analyze complex problems using critical thinking and laboratory experiments to create effective shipping solutions to maintain temperature control and physical protection.
- Provide subject matter expertise and ensure scientific rigor, technical problem solving and execution excellence in support of the portfolio of work, including interrogation of the data/ science through technical reviews and exploring alternative ways to view and solve problems to achieve results.
- Ensure thorough engineering and distribution packaging science is applied to deliverables for new product introductions and technology transfers across the network.
- Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies.
- Collaborate with cross-functional teams to evaluate processes and shipping systems, resolving excursion issues, and implementing corrective actions.
- Develop and maintain strong relationships with internal stakeholders, including commercialization, quality, analytical, regulatory, manufacturing, and Supply Chain to facilitate effective technical support.
- Manage a portfolio of work, holding the team accountable to deliver on priorities.
- Document preparation, maintenance, and review of documentation including specifications, testing protocols, testing reports, technical memos and supplier assessments
- 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
- Bachelor of Science (BS) in packaging, mechanical, chemical, biochemical engineering, pharmaceutical science or chemistry or related fields with twelve (12) years of relevant 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 ten (10) years of relevant 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 relevant 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 technical writing and project management capabilities.
- Understanding of new product introduction, commercial supply, lifecycle management.
- Proven track record of driving continuous improvement and implementing best practices in technical support.
- Strong communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.
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 the EEOC Know Your Rights and EEOC GINA Supplement pages.
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 guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is $126,500.00 - $199,100.00. 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
Hazardous Material(s): n/a
Required Skills: Applied Engineering, Change Management, Combination Products, Compliance Packaging, Cross-Functional Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Management Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management, Root Cause Analysis (RCA), Social Collaboration, Technical Leadership
Job Posting End Date: 10/11/2025
#J-18808-Ljbffr€106769 - €168044 monthly