Manager, Technical Lead, Project Management CSO Packaging & Labeling

Bristol-Myers Squibb - New Brunswick, NJ

Full-time - Mid Level

New Brunswick, NJ

Chemical Manufacturing

About the position

Working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. As a member of our Clinical Supply Operations team, you will play a pivotal role in the supply of drug products administered to patients in clinical studies worldwide. The team works closely with partners to deliver quality products safely, efficiently, and on time while operationalizing innovative technologies that will deliver the transformative medicines of tomorrow. You will have the opportunity to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. In this role, you will support the delivery of clinical supplies through effective management of assigned projects. You will manage multiple projects, liaising with responsible Trial Supply Managers on aspects of clinical supplies packaging and labeling design and study requirements. Ensuring production schedules meet agreed upon on-time delivery dates of finished supplies will be a key responsibility. You will develop detailed time and event schedules, manage and track all activities and milestones related to assigned projects, and coordinate the availability of all deliverables such as drug products and components. Your responsibilities will also include generating internal packaging and labeling production orders in accordance with the clinical trial design and all relevant regulatory requirements. You will be responsible for the creation and/or release of Bill of Materials and process orders in SAP for assigned projects, executing all required SAP transactions such as goods receipt and goods consumption. You will ensure that Bill of Material structures are consistent with the requirements of Independent Requirement Order (IRO) and Packaging Specification (PS). Additionally, you will compile supporting documentation and deliver a body of evidence (batch records) that supports the release of finished supplies for clinical use, liaising with Quality Assurance to secure release of finished supplies. You will also manage external manufacturing transactions in SAP and sample execution, ensuring pricing and terms in label vendor quotations are consistent with MSA. Your role will involve reviewing and approving vendor-generated label proofs and production orders, ensuring regulatory and CGMP compliance of activities in assigned areas of responsibility. You will identify opportunities for improving business processes and participate in project teams focused on continuous improvement. This position requires a Bachelor's degree or equivalent in pharmacy, engineering, business, or life sciences, along with 3 - 5 years of relevant experience in the pharmaceutical industry or related healthcare environment. Knowledge of ERP/MRP (SAP) systems and supply chain principles is highly preferred, as is experience in a cGMP environment. Strong project management skills, solid oral and written communication skills, and good decision-making and organizational skills are essential for success in this role.

Responsibilities

• Supports delivery of clinical supplies through effective management of assigned projects.
• Manages multiple projects and liaises with responsible Trial Supply Managers on aspects of clinical supplies packaging and labeling design and study requirements.
• Ensures production schedules meet agreed upon on-time delivery dates of finished supplies.
• Develops detailed time and event schedules, manages and tracks all activities and milestones related to assigned projects.
• Responsible for coordinating availability of all deliverables (e.g. drug product and components, randomization file and label text).
• Generates internal packaging and labeling production orders in accordance with the clinical trial design and all relevant regulatory requirements for assigned projects.
• Responsible for the creation and/or release of Bill of Materials and process orders in SAP for assigned projects, including relevant checks on order accuracy.
• Executes all required SAP transactions such as goods receipt and goods consumption.
• Assures Bill of Material structures are consistent with the requirements of Independent Requirement Order (IRO) and Packaging Specification (PS).
• Converts planned orders (print and production) into process orders completing all required user fields and adding long text as required.
• Executes TECO transaction on completed process orders.
• Compiles supporting documentation and delivers a body of evidence (batch records) that supports 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; generates and approves project specifications for label print and production.
• Manages external manufacturing transactions in SAP and sample execution.
• Manages and tracks all activities and milestones related to outsourced work and other departmental projects as assigned.
• Ensures pricing and terms in label vendor quotation is consistent with MSA.
• Circulates purchase justification memos and issues purchase orders in accordance with company policy.
• Reviews and approves vendor generated label proofs and other related documents.
• Reviews and approves vendor generated production orders and other related documents (i.e. change orders).
• Ensures regulatory and CGMP compliance of activities in assigned areas of responsibility, through monitoring and management of performance and reporting any deviations immediately to the appropriate management and Quality unit.
• May enter change controls and deviations into quality management system and conduct investigations as assigned.
• Works cross-functionally with individuals and project teams in various areas.
• Identifies opportunities for improving business processes and/or participates on project teams that are focused on continuous improvement.
• Participates in assigned training including CGMP and safety training.
• Authors and reviews procedural documents.

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 highly preferred.
• Experience in cGMP environment, preferably clinical.
• Demonstrates ability to plan, manage and execute multiple projects and to deliver against critical timelines in a fast-paced, rapidly changing environment.
• Strong project management skills.
• Possesses solid oral and written communication skills.
• Good decision making and organizational skills.
• Demonstrates ability to effectively communicate ideas and to influence others to achieve results.

Benefits

• Competitive salary
• Wide variety of competitive benefits, services and programs
• Opportunities for professional growth and development
• Flexible work environment