Senior Specialist, Planning & Scheduling - Onsite

Job Description Sr. Specialist, Clinical Supply Operations (P3) Position Description The Sr. Specialist, Clinical Supply Operations (CSO) is responsible to support our clinical supply packaging & distribution operations at our company's Rahway, NJ site. This role will collaborate with a diverse range of stakeholders, subject matter experts, and customers both within and outside of Global Clinical Supply (GCS). Your responsibilities will be instrumental in driving innovative initiatives, ensuring operational efficiency, and maintaining compliance, all while supporting our commitment to business continuity. This role will report into Associate Director, Packaging & Distribution Support at our company's Rahway site. Key responsibilities of the Sr. Specialist, Clinical Supply Operations include: Process Execution | Continuous Improvement Supporting the operational efficiencies and initiatives of clinical supply operations; including packaging and distribution 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. Lead or participate in area and process walkthroughs to assess compliance, identify process improvements, and execute corrective and preventive actions (CAPAs) ensure adherence to regulatory requirements. Serve as a Subject Matter Expert (SME), providing area and process overviews to stakeholders upon request. Author and/or participate in investigations of atypical events, clinical complaints, and CAPAs, as required. Ensure accurate documentation of SAP transactions, including pre‑execution and post‑execution reviews of batch documentation per established procedures. Leadership | Communication Support daily Tier meetings to ensure effective communication and information flow-up and down through the organization. Provide ongoing feedback and coaching to employees to support performance, development, and accountability. Promote and maintain a culture of inclusion, consistency, and positive employee relations at both the team and site levels. Actively support the team in troubleshooting issues to minimize downtime and maintain product quality. Champion standard work to ensure consistent application of best practices across operations. Foster a strong and effective safety culture through visible actions, coaching, and clear prioritization of a safe environment.

Position Qualifications:

Education Minimum Requirement:

Bachelor's degree in engineering, Supply Chain, Business, or related field.

Required Experience and Skills:

Minimum of 5 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. Ability to operate effectively independently and collaboratively within teams Ability to manage multiple priorities and coordinate people/resources to meet a production schedule Outstanding decision-making skills and strengths in project management and team alignment Knowledge of cGMPs, data management, collection, and analysis Proficient in Microsoft Office (Word, Excel, etc.) SAP (or equivalent) experience strongly preferred Strong interpersonal, communication, organizational and problem-solving skills, coupled with the ability to engage and influence cross-functional stakeholders

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 scheduling and capacity modeling to ensure optimal resource allocation. Demonstrated ability to drive change and improve operational effectiveness

Required Skills:

Apoyo al rendimiento, Buenas prácticas de fabricación (BPF), Coordinación de logística, Escritura de procedimiento operativo estándar (SOP), Gestión de suministros clínicos, Impulso de la mejora continua, Mejoras de procesos, Métricas de la cadena de suministro, Operaciones de ensayos clínicos, Planificación de Producción, Requisitos regulatorios

Preferred Skills:

Current Employees apply HERE Current Contingent Workers apply HERE Solo para residentes en EE. UU. y

Puerto Rico:

Nuestra empresa está comprometida con la inclusión, velando para que las personas puedan participar en un proceso de contratación que muestre sus verdaderas capacidades. Haga clic aquí si necesita adaptaciones durante el proceso de solicitud o contratación. Somos un empleador que ofrece igualdad de oportunidades, comprometido con fomentar un lugar de trabajo inclusivo y diverso. Todos los solicitantes calificados recibirán consideración para el empleo sin distinción de raza, color, edad, religión, sexo, orientación sexual, identidad de género, origen nacional, estado de veterano protegido, o estado de discapacidad, u otras características protegidas legalmente aplicables. Para obtener más información sobre los derechos personales bajo las leyes de empleo de igualdad de oportunidades de los EE. UU., visite: EEOC Conozca sus derechos EEOC Suplemento GINA Transparencia de pago No discriminación Orgullosos de ser una empresa que adopta el valor de reunir a personas diversas, talentosas y comprometidas. La forma más rápida de lograr una innovación revolucionaria es cuando las ideas diversas se unen en un entorno inclusivo. Alentamos a nuestros colegas a desafiar respetuosamente el pensamiento de los demás y abordar los problemas de manera colectiva. 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 $106,200.00 - $167,200.00 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 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:

Contrato indefinido

Relocation:

No relocation

VISA Sponsorship:

No Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable Shift:

1st -

Day Valid Driving License:

No Hazardous Material(s):

No Job Posting End Date:

05/11/2026 •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. Nuestra compañía es líder mundial de atención de la salud con una cartera diversificada de medicamentos con receta, vacunas y productos de salud animal. La diferencia entre potencial y logro radica en la chispa que alimenta la innovación y la creatividad; este es el espacio donde hemos codificado nuestro legado durante más de un siglo. Nuestro éxito está respaldado por la integridad ética, el impulso hacia adelante y una misión inspiradora para lograr nuevos hitos en la atención sanitaria global.