Manager, Technical Lead, Project Management CSO Packaging & Labeling

Bristol-Myers Squibb - New Brunswick, NJ

Full-time - Mid Level

Hybrid - New Brunswick, NJ

Chemical Manufacturing

About the position

The Clinical Supply Operations team at Bristol Myers Squibb is responsible for the supply of drug products administered to patients in clinical studies worldwide. This role involves managing multiple projects related to clinical supplies, ensuring timely delivery, and maintaining compliance with regulatory requirements. The position offers the opportunity to positively impact patients' lives while supporting personal career development in a dynamic and diverse environment.

Responsibilities

• Supports delivery of clinical supplies through effective management of assigned projects.
• Manages multiple projects and liaises with Trial Supply Managers on clinical supplies packaging and labelling design.
• Ensures production schedules meet agreed upon on-time delivery dates of finished supplies.
• Develops detailed time and event schedules, managing and tracking all activities and milestones related to assigned projects.
• Coordinates availability of all deliverables including drug product and components, randomization file, and label text.
• Generates internal packaging and labeling production orders in accordance with clinical trial design and regulatory requirements.
• Responsible for the creation and/or release of Bill of Materials and process orders in SAP for assigned projects.
• Executes all required SAP transactions such as goods receipt and goods consumption.
• Assures Bill of Material structures are consistent with Independent Requirement Order (IRO) and Packaging Specification (PS).
• Converts planned orders into process orders, completing all required user fields and adding long text as required.
• Compiles supporting documentation and delivers batch records that support the release of finished supplies for clinical use.
• Liaises with Quality Assurance to secure release of finished supplies.
• Supports externally managed projects via outsourcing project management and generates project specifications for label print and production.
• Manages external manufacturing transactions in SAP and sample execution.
• Tracks all activities and milestones related to outsourced work and departmental projects as assigned.
• Ensures pricing and terms in label vendor quotations are consistent with MSA and issues purchase orders in accordance with company policy.
• Reviews and approves vendor generated label proofs and production orders, ensuring regulatory and CGMP compliance.
• Identifies opportunities for improving business processes and participates in continuous improvement project teams.

Requirements

• Bachelor's degree or equivalent in pharmacy, engineering, business or life sciences.
• 3 - 5 years relevant experience in the pharmaceutical industry or related healthcare environment.
• Knowledge of ERP/MRP (SAP) systems and supply chain principles is highly preferred.
• Experience in a cGMP environment, preferably clinical.
• Demonstrates ability to plan, manage and execute multiple projects and deliver against critical timelines in a fast-paced environment.
• Strong project management skills.
• Solid oral and written communication skills.
• Good decision making and organizational skills.

Nice-to-haves

• Experience in clinical trial management.
• Familiarity with regulatory compliance in clinical supply operations.

Benefits

• Competitive salary and benefits package.
• Opportunities for professional development and career growth.
• Flexible work environment with options for hybrid work models.