Associate Director, Planning & Scheduling

Job Description

Associate Director Clinical Supply Operations (P4)

Position Description

The Associate Director Clinical Supply Operations (CSO) is responsible to support our clinical supply packaging distribution and label printing operations at the Rahway NJ site. This pivotal role will collaborate with a diverse range of stakeholders subject matter experts and customers both within and outside of Global Clinical Supply (GCS). Your leadership will be instrumental in driving innovative initiatives ensuring operational efficiency and maintaining compliance all while supporting our commitment to business continuity.

Key responsibilities of the Associate Director Clinical Supply Operations include:

• Supporting the operational efficiencies and initiatives of clinical supply operations; including packaging distribution and label print operations in Rahway NJ.

• Assist in ensuring operational readiness for the expanding landscape of on-site clinical capabilities.

• Lead efforts to sustain inspection readiness by implementing standardized workstreams.

• Ensure efficient and compliant processes by taking ownership of the development and enhancement of standard operating procedures (SOPs) at both local and global levels.

• Effectively collaborate with other CSO nodes optimizing interactions with partner groups such as Packaging Label Room Operations Planning Quality Master Planning Bulk Manufacturing and Analytical (for cleaning swabbing and investigations) to support business continuity and portfolio requirements.

• Establish strong partnerships with quality teams to ensure agility and responsiveness in meeting portfolio demands.

• Adaptively manage responsibilities and activities across CSO workstreams to support business objectives leveraging Tier processes as appropriate.

• Collaborate with on-site upstream drug product manufacturing to implement integrated operations within clinical supply.

• Identify opportunities for innovation and process improvement supporting necessary changes to enhance operational effectiveness.

Position Qualifications:

Education Minimum Requirement: Bachelors Degree in Engineering Supply Chain Business or related field.

Required Experience and Skills:

• Minimum of 7-10 years of experience in production operations technical project management engineering or management roles within the pharmaceutical industry with a solid understanding of clinical supply needs Good Manufacturing Practices (GMP) packaging and distribution operations.

• Strong understanding of current Good Manufacturing Practices (cGMP) including compliance with FDA and EMEA regulations.

• Proven experience in leading teams and managing complex projects effectively.

• Demonstrated ability to lead cross-functional teams through all phases of project planning and execution.

• Experience in collaborating with vendors and external partners to achieve project objectives.

• Ability to work effectively across organizational boundaries and build strong collaborative relationships with diverse groups.

• Strong skills in stakeholder management and the ability to build and maintain cross-functional networks.

• Excellent communication skills with the ability to engage effectively with various global professional levels and external stakeholders.

• Demonstrated ability to prioritize tasks and manage multiple responsibilities efficiently.

• Proficient in the Microsoft Office Suite and other relevant applications.

Preferred Experience and Skills:

• Direct experience in pharmaceutical packaging and distribution operations is highly valued.

• Experience with cold chain clinical supply including packaging and distribution operations.

• Knowledge of SAP systems and their application in supply chain management.

• Possession of Six Sigma certification (e.g. Green Belt or Black Belt).

• A demonstrated dedication to solving complex problems through innovative thinking and imaginative strategies.

• Understanding of scheduling and capacity modeling to ensure optimal resource allocation.

Current Employees apply HERE

Current Contingent Workers apply HERE

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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 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

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 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

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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.

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