Director, Clinical Supply Packaging

Job Description

Global Clinical Supply (GCS) organization is within our Company's Research Laboratories and is accountable for managing the 'end-to-end' integrated clinical supply chain across all our Research & Development Division portfolio to enable the execution of any clinical trial using our Company's asset. GCS supports more than 300 Phase I-IV clinical trials run inhouse, 400+ outsourced or run by partners as well as our Company's IIS clinical trials GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites across more than 60+countries, all in accordance with US and WW regulations, company policies and Standard operating procedures.

West Point site is the biggest site in our operations network. The packaging team plays a critical role in the clinical supply chain and flowless execution is paramount to meet the timelines and ensure business continuity for the portfolio. The Execution Operation head will be part of the WP CSO LT

The role is accountable of ensuring end to end operational excellence and execution in the packaging space of global clinical supplies executed in WP and is also accountable of the day-to-day management of the vendors supplying components and machinery necessary for execution of our products.

The Director will be a key part of WP CSO leadership team and as such will actively collaborate in update WP CSO strategy.

As organizational leader the role will be accountable to shape packaging and distribution (execution center) organization to the current needs of the CS (Clinical Supplies) chain and our Research & Development Division portfolio.

Primary activities include, but are not limited to:

• Oversee all operations and packaging floor in buildings 78A and 69D, including reconfiguration of current space to maximize throughput, staff utilization to minimize errors, and ensuring audit preparedness at all times.
• Ensure efficient and compliant processes, including review and harmonization of all SOPs with WAG and Rahway. After harmonization, simplification and quality alignment to ensure agility and speed can be accommodated as required for the portfolio
• Controls scheduling activities and ensure collaboration across other GCS work center to enable business continuity and portfolio needs
• Talent attraction, development and retention
• Performance management; including utilization of existing P3 and P4 to begin managing contractor and our Company's CPT staff
• Capacity modeling and resource management; including presentation to LT and maintenance of metrics for each role within the packaging floor
• Oversight of execution of vendors in the component and machinery space in collaboration with cross-functional internal groups
• Close collaboration with Quality, Procurement, Finance, other GCS departments
• Alignment with WAG, including partner group interaction optimization (Distribution, LR, Ops Planning, Quality, Master planning, Bulk manufacturing, Analytical for cleaning/swabbing/investigations)
• Close collaboration with GCTO and Regulatory to ensure regulatory needs are included in the CFGs and on time arrival of our products are ensured right first time
• Seek ways to innovate and work smarter, removing barriers for the team and supports change as needed.
• Lead a mixed team of our Company employees, union and contractors.

Education & Experience:

• At least 10 years of experience in Clinical Supply Chain and/or Clinical trials including exposure to Quality and/or continuous improvement activities.
• Bachelor's degree required. Preferably in Engineering, Science or Operations Management. An advanced degree is preferred but not required. An MBA or other business degree, in addition to the required science or engineering education, is beneficial.
• Understanding of clinical supply needs, experience in supply chain operations within a GMP environment.
• Strong understanding of cGMP, including FDA and EMEA requirements.
• Experience in packaging will be highly valued.
• Experience in leading teams, developing talent, mentoring or leading complex projects.

Preferred Experience and Skills:

• Operations Management Certification (I.e., APICS)
• Six Sigma certification (i.e., Green or Black Belt).
• Project management, lean six sigma, detailed scheduling practices
• Able to organize a large team, upskill talent, and motivate for future success
• Comfortable with excel and Microsoft systems
• A dedication to solving complex and challenging problems with a creative mind and imaginative strategies.
• Understanding of scheduling and capacity modeling to ensure appropriate resourcing
• Ability to prioritize
• Demonstrated ability to communicate clearly, effectively with different global professional levels and external stakeholders.

PSCS

GCScareer

Required Skills:

Accountability, Accountability, Change Agility, Clinical Supplies Management, Clinical Supply Chain Management, Clinical Trials, Cross-Functional Communications, Dispatching, Distribution Management, Driving Continuous Improvement, GMP Compliance, Good Manufacturing Practices (GMP), Inventory Control Management, Lean Six Sigma (LSS), Master Batch Records, Operational Excellence, Organizational Change Management, Outsourcing, Pharmaceutical Packaging, Production Planning, Project Leadership, Project Management, Purchasing Management, Recordkeeping, Requisition Management {+ 4 more}

Preferred Skills:

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".

The salary range for this role is

$153, $242,200.00

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

12/18/2025

• 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:R378449