Senior Specialist, Planning & Scheduling - Onsite

MSD•Rahway, NJ

4d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in engineering, Supply Chain, Business, or related field.
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
Clinical Supplies Management
Clinical Trials Operations
Driving Continuous Improvement
Good Manufacturing Practices (GMP)
Logistics Coordination
Performance Support
Process Improvements
Production Planning
Regulatory Requirements
Standard Operating Procedure (SOP) Writing
Supply Chain Metrics

Nice To Haves

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
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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”.
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 place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Responsibilities

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.
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.