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