Job Information
Merck Director, Packaging Shipping Systems (Logistics and Distribution Technology) in Durham, North Carolina
Job Description
Reporting into the director of Distribution Components and Systems, the Director, Logistics and Distribution Technology will be responsible and accountable for technical support for distribution and logistics of Drug Substance, Dug Product and Finished Goods images globally. The organization is responsible for providing Subject Matter Expert technical support to the internal and external manufacturing sites as well as Third Party Logistics providers to ensure robust, compliant supply. The organization provides guidance on distribution qualification activities for shock and vibration as well as thermal protection system testing and qualification and leads execution of qualification of complex systems. The Director will lead a team of cross functional technical experts to characterize the real-world experience and enable translation into standard work development for distribution related characterization across packaging platforms to ensure protective packaging designs.
The successful candidate will have organizational, technical, and project leadership experience commensurate with leading a global, cross-modality technical teams. The leader will also be responsible for executing on priorities for the organization and the successful completion of projects, through strong scientific excellence, technical rigor, robust problem solving and strategic decision making. The candidate will be expected to build inclusive, collaborative partnerships with internal and external stakeholders such as packaging and manufacturing sites, supply chain management, regulatory, analytical, and packaging commercialization. The successful candidate will display ownership and make informed cost/benefit decisions based on analysis of inputs, outcomes, risks, and company-wide prioritization.
Essential Responsibilities:
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.
Collaborate with cross-functional teams and stakeholders to ensure that all platforms meet safety, efficacy, quality, and robust supply standards.
Ensure thorough engineering and distribution packaging science is applied to deliverables for new product introductions and technology transfers across the network.
Lead 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 scientific rigor, technical problem solving and execution excellence 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.
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.
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
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 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 twelve (12) 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
Required Skills and Experience:
Demonstrated experience in a leadership role, managing technical team in support of packaging or distribution operations, or related functions.
Demonstrated experience with development and qualification of package design and/or distribution/ transportation technologies for pharmaceutical products including parenteral and/or medical device and combination products.
Strong understanding of 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.
In-depth knowledge of global regulatory requirements for distribution including good distribution practices.
Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.
Strong problem-solving and decision-making skills with an ability to interrogate the science, identify true requirements, and detect critical flaws
Able to guide key activities including development of standard work, investigations, and problem solving
Proven track record of driving continuous improvement and implementing best practices in technical support
Strong strategic and analytical thinking, with a focus on driving continuous improvement and implementing best practices in technical support.
Ability to determine areas of potential risk, generate gap analysis and mitigation strategies
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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 (https://www.msdprivacy.com/us/en/CCPA-notice/)
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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range:
$153,800.00 - $242,200.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .
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:
02/8/2025
*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: R332209
Merck
- Merck Jobs